Parent’s Choice Formula Recall 2022 & Baby Food Safety Alerts: What You Need To Know
Is there any Walmart (Parent’s Choice) formula or baby food recall in 2022?
No, there isn’t any recall on Parent’s Choice Formula in 2022. However, Walmart removed Parent’s Choice Baby Wipes from store shelves over quality issues.
The formula shortage caused by the massive recall of Similac products by Abbott Nutrition and supply issues even before the recall led many parents to try alternatives, such as Parent’s Choice baby formula. But even store brands are difficult to find.
Does Walmart have toxic heavy metals in its baby food and formula?
Exposure to heavy metals like arsenic and mercury can cause permanent damage to your baby’s developing brain. Even at low concentrations, it can lead to IQ decrease and antisocial behavior. (1)(2)
But as much as 95% of baby food products may contain harmful chemicals and toxic metals, with many coming from the most popular brands such as Walmart (Parent’s Choice). (3)(4)
Like baby foods, some infant formulas may also contain heavy metals. (3)(4)
Aside from the problem with heavy metals, there have been several infant formula recalls due to contamination with insects, foreign matter, pathogens, and other safety issues.
Drinking or eating contaminated products can lead to various health problems, gastrointestinal issues, or even death in serious cases. So, it’s always important to watch out for infant formula and baby food recalls.
Some parents may choose to breastfeed after hearing about these worrisome reports. It may be ideal for them, especially because the AAP (American Academy of Pediatrics) recommends giving your baby breast milk exclusively from birth to six months. (5)
But many parents also need or wish to provide infant formula for their babies.
There are many formula options for you to choose from, but always make sure to consult with your pediatrician to check if these products are safe. Also, it’s a good idea to regularly monitor any recent recalls or safety concerns, especially regarding the baby food or formulas your baby is using.
Parent’s Choice: What Baby Formula Is On Recall 2021?
In February 2021, a congressional report presented by the Congressional Subcommittee on Economic and Consumer Policy called out several popular baby food manufacturers for having products tainted with dangerous levels of toxic heavy metals. (3)(6)
Parent’s Choice (Walmart) is among the brands included in the Congressional reports. But like the rest of the manufacturers, it didn’t issue any recall on its baby foods or formulas. (3)(6)
The brand has also figured in other baby food safety reports, including the comprehensive heavy metal tests conducted by HBBF (Healthy Babies Bright Futures) on food and formula in 2019. (3)
But even then, the brand hasn’t responded to calls for product recall from worried parents. (3)
The following recall has been the only one issued by Parent’s Choice, but it’s not related to the Subcommittee’s findings or any baby food safety report by independent groups:
Parent’s Choice Advantage Infant Formula Milk (Powder With Iron) Recall 2019
- Date Recalled: June 21, 2019
- Company Name: Perrigo Company plc (produces milk for Walmart)
- Reasons For Recall: Sold exclusively at Walmart stores, this batch was recalled for the potential presence of metal foreign matter. (7)
- Walmart recalled the formula after receiving a customer report about the presence of metals in the milk they purchased. (7)
- Affected Products: Lot code C26EVFV, with “use by” date code of “26FEB2021” (February 26, 2021), found at the bottom of the package. (7)
- This recall affects a total of 23,388 containers (35-ounce, 992-gram containers)
- Return or Refund Processing: Customers with any concerns should contact Perrigo Consumer Affairs at 866-629-6181 or [email protected]
- Customers can also process their refund at any Walmart store.
According to the recall advisory, the lot was recalled “out of an abundance of caution,” stemming from the consumer reports. But no adverse incidents have been reported. (7)
The recall didn’t involve other products or lot codes. (7)
Parent’s Choice Formula In HBBF Baby Food Safety Reports
In 2019, HBBF (Healthy Babies Bright Futures) commissioned comprehensive tests on baby food and formula to check for heavy metals and other toxic chemical contents. (3)
The FDA’s limit is 100 ppb (parts per billion) of inorganic arsenic for infant rice cereals. (4)
The FDA also set these maximum limits for bottled water (may apply to food): (4)
- 10 ppb inorganic arsenic
- 5 ppb cadmium
- 5 ppb lead
The HBBF expressed alarm after getting the following results: (3)
- Lead: 94% of baby foods
- Cadmium: 75% of baby foods
- Arsenic: 73% of baby foods
- Mercury: 32% of baby foods
They also got the following results for the formulas they tested: (3)
- Lead: 100% of baby formulas
- Cadmium: 62% of baby formulas
- Arsenic: 62% of baby formulas
- Mercury: 7.7% of baby formulas
These are the results for Parent’s Choice Organic Infant With Iron Milk-Based Powder (Stage 1 through 12 months) from HBBF’s tests: (3)
- Arsenic: 3.2 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 3.9 ppb
- Cadmium: 0.7 ppb
- Mercury: <0.134 ppb
Although these levels were within the limits, the HBBF hasn’t cleared the company of toxic metals because the infant formula has measurable heavy metal levels.
Parent’s Choice Baby Food Recalls 2021
Walmart didn’t recall any baby food products or infant formula in response to the Congressional Reports. But it recalled these rice cereals with advice from the FDA (Food and Drug Administration): (8)
Parent’s Choice Rice Baby Cereal Recall
- Date Recalled: October 8, 2021
- Reasons For Recall: Routine sampling by the FDA shows that three lots of Walmart’s rice baby cereals contain higher levels of naturally occurring inorganic arsenic than the government standard. (8)
- No other lots or products were recalled.
- Company: Maple Island Inc. (produces baby food products for Walmart)
- Return or Refund Processing: Email [email protected] or call 1-800-369-1022
Affected products are the following containers of Parent’s Choice Rice Baby Cereal (8-oz. packages), all with UPC number 00681131082907 from these lot numbers: (8)
- Lot 21083 with a “best if used by date” code of JUN 24 2022
- Lot 21084 with a best if used by date code of JUN 25 2022
- Lot 21242 with a best if used by date code of NOV 30 2022
No adverse reactions or illnesses have been reported in this recall. (8)
No other Parent’s Choice (Walmart) products or lots have been affected. (8)
Affected customers were advised to discard the recalled products or return them to Walmart stores for a full refund. (8)
According to the recall advisory, Maple Island Inc. conducted tests on both the raw materials and finished products for Parent’s Choice Rice Baby Cereal. These test results complied with the FDA’s guidelines, but the company decided to issue the nationwide recall out of an abundance of caution. (8)
The company explained that trace elements are widely present in the environment, whether in soil, water, or food; the FDA has recognized this. The government agency recommends reducing exposure to these toxic elements to minimize the potential long-term negative effects on infants and children’s developing brains. (8)
Alarming 2021 Government Report Findings
In February 2021, a congressional report presented by the Subcommittee on Economic and Consumer Policy called out the following popular baby food manufacturers for having products tainted with dangerous levels of toxic heavy metals:
- Walmart Inc. (Parent’s Choice)
- Nurture, Inc. (HappyBABY and HappyTOT)
- Beech-Nut Nutrition Company (Beech-Nut)
- Hain Celestial Group, Inc. (Earth’s Best Organic)
- Campbell’s Plum Organics
- Sprout Foods, Inc. (Sprout Organic Foods)
The same Subcommittee released a follow-up report in September 2021. (6)
This new report shows that the brands are still producing baby products that may have high levels of heavy metals.
Companies such as Walmart failed to disclose these alarming results to the public. They continue to keep the baby food products on the market, thereby failing to protect consumers.
Walmart Inc. (Parent’s Choice) In Congressional Reports
According to the report, Walmart refused to cooperate and didn’t provide the Subcommittee with their internal policies or baby food test results. (4)
The following data come from the independent tests conducted by HBBF (Healthy Babies Bright Futures): (3)
Parent’s Choice (Walmart) Organic Strawberry Rice Rusks – Stage 2 (for 6+ months)
- Arsenic: 108 ppb
- Inorganic Arsenic: 66 ppb
- Lead: 26.9 ppb
- Cadmium: 2.4 ppb
- Mercury: 2.04 ppb
Parent’s Choice (Walmart) Little Hearts Strawberry Yogurt Cereal Snack – Stage 3 (for 9+ months)
- Arsenic: 56.1 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 5.2 ppb
- Cadmium: 26.1 ppb
- Mercury: 0.941 ppb
Parent’s Choice (Walmart) Organic Infant Milk-Based Powder With Iron (Stage 1 through 12 months)
- Arsenic: 3.2 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 3.9 ppb
- Cadmium: 0.7 ppb
- Mercury: less than 0.134 ppb
Parent’s Choice (Walmart) Carrot – Stage 2 (for 6+ months)
- Arsenic: less than 2 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 2.3 ppb
- Cadmium: 11.2 ppb
- Mercury: less than 0.128 ppb
Parent’s Choice (Walmart) Sweet Potato – Stage 1 (for 4-6 months)
- Arsenic: 4.3 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 4.3 ppb
- Cadmium: 1.4 ppb
- Mercury: less than 0.141 ppb
Parent’s Choice (Walmart) Organic Butternut Squash Vegetable Puree – Stage 2 (for 6+ months)
- Arsenic: less than 2.2 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 4.3 ppb
- Cadmium: 0.9 ppb
- Mercury: less than 0.138 ppb
Parent’s Choice (Walmart) Organic Strawberry Carrot and Quinoa Fruit & Veg Puree – Stage 2 (for 6+ months)
- Arsenic: less than 2.5 ppb
- Inorganic Arsenic: (not measurable)
- Lead: 3.6 ppb
- Cadmium: 1.8 ppb
- Mercury: less than 0.125 ppb
Walmart Inc. (Parent’s Choice) In Consumer Reports Food Safety Test
Parent’s Choice didn’t just figure in the Congressional reports. It has also been called out for its questionable contents by Consumer Reports in 2018.
Consumer Reports tested 50 different baby foods for heavy metals and got these alarming results: (9)
- Nearly 68% of baby food products from popular and niche brands may have high levels of at least one toxic metal.
- There are 15 baby foods that may have higher health risks if eaten daily
- Products that have rice or sweet potatoes may contain higher toxic metal levels
- Despite being more costly, organic foods can have the same amount of heavy metals like those found in regular baby foods
Based on the tests by Consumer Reports, this product is categorized as “more concern” due to high toxic metal content and is best served with a daily serving limit: (9)
Parent’s Choice (Walmart)
- Little Puffs Cereal Snack, Strawberry Apple (less than 1.5 servings)
Baby Formula Shortage 2022
Update: May 2, 2022
It’s estimated that as much as 30% of baby formula brands could be sold out in the US, according to research firm Datasembly, based on market research as of March 2022. (10)
With as many as 75% of babies in the US possibly given formula by six months of age, the shortage makes many parents worried. (11)
It was first thought that the formula shortage only affected Similac because Abbott Nutrition recalled different formulas. However, parents looking for alternatives discovered that even other brands are also unavailable.
What’s alarming is that the prices of available infant formula have increased in some places due to the high demand but low supply.
The average cost of popular baby formula brands is up by as high as 18%, according to a report by CBS News. (12)
Samantha Klaja, a mom from Hamburg in Buffalo, New York, said: (13)
“You can get a store brand of formula for $19.99, but the problem is the store brand is not available. So you have to go buy the actual brand. I use Parent’s Choice of Walmart for $19.99, but it’s not available. You can’t find any store brand anywhere. So, you have to buy this $45 brand formula.”
Moms are getting stressed out over their difficulties finding any formula for their babies. Some said that their babies experienced going an entire day without food because they couldn’t find any formula no matter where they searched.
Cassidy Rogers, a mom from Orchard Park in Erie County, New York, narrated: (13)
“My baby almost went without food for a least a day because I couldn’t find it and it was expensive and had almost no money to get it. I struggle sometimes to find it.”
Klaja agrees that it has truly become a struggle to find infant formula amid the shortage: (13)
“It’s very stressful. I feel like I ultimately kind of am failing as [a] mother because I can’t provide for my child the way I need to. But I know it’s not my fault – I didn’t create a shortage.”
Alternatives To The Recalled Infant Formulas (Amid The Shortage & Beyond)
Update: July 22, 2022
Many parents continue to face difficulties in finding infant formula.
Here are some US brands for you to try with your doctor’s approval, as long as your little one doesn’t require specialized formulas:
- Bobbie Organic Infant Formula
- Serenity Kids A2 Toddler Formula (Use our code MHC for 15% off first-time orders, too!)
- ByHeart Baby Formula
These European formulas are also worth considering, espeically if you’re looking for the best organic options for your baby:
IMPORTANT: Please consult your healthcare provider or pediatrician before switching to any of these formulas. Many of these European formulas aren’t approved by the FDA, but many parents still prefer them over US brands.
Alternatives To Baby Formula & What To Avoid
Finding infant formula can be a big challenge. Still, it’s also important that you avoid giving your baby something that might harm them.
Pure cow’s milk shouldn’t be given to babies below one year of age. It doesn’t matter if it’s pasteurized. (14)
Cow’s milk contains too many proteins and minerals that your baby’s still developing tummy and kidneys can’t handle yet. It puts them at risk for intestinal bleeding, which can be deadly if not diagnosed and treated immediately. (14)
Try to avoid the following without your pediatrician’s approval: (14)
- Almond milk
- Cashew milk
- Coconut milk
- Oat milk
- Rice milk
- Soy milk
Other milk options to avoid:
- Condensed milk – because of its high sugar content, which can lead to type 2 diabetes, heart disease, unhealthy weight gain, and obesity
- Donor breastmilk, unless it’s from a screened donor
Although human donor milk (pasteurized) can be an alternative if your breastmilk isn’t available, the FDA cautions against the possible health risks from unscreened donors: (15)
- Hormonal supplements or prescription drugs that can affect your baby – including Brexanolone (an FDA-approved drug for postpartum depression treatment)
- Infectious diseases, including HIV (human immunodeficiency virus)
- Chemical contaminants, including illegal drugs
Evaporated milk is used in some places, such as parts of Canada, as an alternative to breastmilk or baby formula. (16)
However, ask your pediatrician before giving it to your baby amid the formula shortage. Studies show that babies consuming evaporated milk can be more likely to experience iron deficiency. Your doctor might recommend iron supplementation. (16)
Limits & Rationing
The baby formula shortage is getting worse that retailers like Target, Walgreens, and CVS Health, have put limits on the number of baby formula products a customer can buy: (12)
- Target limits customers to four cans/boxes of a given formula product at a time.
- CVS Health limits (in-store and online) to three baby formula products per purchase.
- Walgreens also limits customers to three baby and toddler formula products per transaction.
States & Cities With The Worst Shortage
Some places have it worse than others. According to Datasembly, the following states are among the hardest hit by the formula shortage, with the out-of-stock percentage higher than 40% in March: (10)
- Minnesota (highest at 54%)
- Rhode Island
- South Dakota
- North Dakota
Datasembly listed the following cities for their highest out-of-stock rates: (10)
- San Antonio (56%)
- Minneapolis (55%)
- Moines (50%)
Reasons For The Shortage
There isn’t any recent recall of Parent’s Choice baby formula products, but why is there a shortage of this item and other baby formulas?
According to Datasembly’s chief executive officer Ben Reich, the shortage reached alarming levels because there was already an ongoing shortage even before the massive Similac recall in February 2022. (10)
Even back in 2021, brands have already struggled to meet the increasing demands.
Datasembly’s market research showed that the out-of-stock rates went from 2-8% during the first seven months to double digits for the rest of 2021. (10)
The out-of-stock rate peaked in January 2022 at 23%. (10)
So, it isn’t surprising that the shortage increased to over 30% in March after Abbott Nutrition recalled Similac, Alimentum, Elecare, and Similac PM 60/40 in February.
FDA Didn’t Stop Abbott Production Despite Knowing About Safety Lapses
Parents and several lawmakers question the FDA (United States Food and Drug Administration) why the agency didn’t issue a recall earlier than its February 2022 advisory. (17)
The FDA’s safety inspection records showed that it knew about possible safety lapses at Abbott’s facility in Sturgis, Michigan, even back in September 2021. (18)(15)
That’s months before Similac was linked to the deaths of two babies in February 2022.
The safety concerns include unsanitary conditions and workers not following proper safety procedures before entering the production area. (18)(15)
Whistleblower Told FDA About Abbott’s Safety Lapses Months Before Recall But Was Reportedly Ignored
Amid the investigation regarding the FDA’s possible judgment error in not issuing a recall immediately, House Appropriations Committee Chair Rep. Rosa DeLauro found a whistleblower who used to work at the Abbott facility. (19)(20)
This former employer wrote a 34-page report detailing the alleged safety lapses at the facility. He alleged that the company falsified records and tampered with time codes in certain products made along with some that tested positive for “micros.” (20)
Some managers allegedly “sanitized” certain records to pass the FDA test. These accusations, including many others, were sent to the FDA in October 2021 but were reportedly “ignored.” (20)(21)
Abbott’s Sturgis Plant Reopens Again After Flooding
Update: July 11, 2022
After a three-week shutdown caused by massive floods in the area, Abbott’s Sturgis plant reopened again on July 1, 2022. The company restarted EleCare production upon reopening, and plans to make specialty and metabolic formulas next. (22)
FDA Plans To Extend Formula Importation Beyond Shortage
The FDA plans to extend formula importation from temporary overseas importers beyond the shortage in a bid to prevent the crisis from happening again. (23)
They will issue further guidance in September on how these companies continue supplying formulas beyond mid-November by meeting the FDA requirements. (23)
FDA Probes Death Of Another Child Who Reportedly Consumed Abbott Formula
Update: June 22, 2022
FDA authorities have launched an investigation into the circumstances of a baby’s death in January after they received a report on June 10 that the child had consumed Abbott formula. (24)
Operation Fly Formula’s Tenth Flight Brings Formula From Mexico
President Joe Biden’s Operation Fly Formula is on its tenth mission to bring formula from across the world to help alleviate the US crisis. (25)
Starting on June 24, flights will arrive in Fort Worth, Texas, from Mexico, to bring a total of 1 million pounds of Gerber Good Start Gentle infant formula (equivalent to approximately 16 million 8-oz bottles). (25)
Abbott Plant Closes Down Again Due To Floods
Update: June 20, 2022
It had just reopened after months of shutting down due to the possible Cronobacter and Salmonella contamination in February 2022, but troubles continue to hound the Sturgis plant. It closed down again due to floods affecting the area. (26)
According to Abbott’s press statement, severe thunderstorms hit Michigan, which resulted in power outages and flood damage that also included areas of their plant. (26)
They have already informed the FDA about this new setback, but the company explained that this will likely delay formula production for a few weeks. (26)
Comprehensive tests with an independent third party need to be done to ensure the plant’s safety before they can resume again with the FDA’s approval. The company said they will resume EleCare production after re-sanitization before starting with Similac and other formulas. (26)
More Formulas Flown In From Across The World
President Joe Biden’s “Operation Fly Formula” continues to bring more formulas from across the world, helping solve the US formula shortage.
Additional arrivals in the middle of June:
- 95,000 cans of Bubs Australia baby formula (380,000 lbs of infant formula equivalent to around 4 million eight-ounce bottles) arrived in LAX from Australia (27)(28)
- 200,000 8-ounce bottles of Kendamil formula from the United Kingdom arrived at Dulles International Airport in Virginia (29)
- 44,000 pounds (equivalent to around 548,000 eight-ounce bottles) of Nestlé Health Science Alfamino and Alfamino Junior from Switzerland arrived at the Louisville International Airport (28)
More arrivals expected by the end of June and the rest of summer:
- 686,350 cans (equivalent to approximately 16.5 million 8 fl oz bottles) of Similac NeoSure and Similac Total Comfort will be shipped by Abbott from their manufacturing facility in Granada, Spain (26)
- 750,000 cans of Danone formula (Aptamil First Infant Milk Stage 1) equivalent to 19 million 8-ounce bottles will arrive Ireland (29)
Recalled Infant Formulas Accidentally Sold In Canada
In Canada, Shoppers Drug Mart accidentally sold recalled Abbott baby formulas due to an “online error,” warns the CFIA (Canadian Food Inspection Agency). (30)
These were the baby formula products recalled in February 2022 and contain the following codes (check the bottom of the package or container):
- The code has K8, SH, or Z2
- The code starts with numbers from 22 to 37
- The expiration date code begins with 4-1-2022 (APR 2022) and subsequent dates
The retail pharmacy giant issued a secondary recall for these recalled Abbott infant formulas. (30)
More Formula-related Infant Deaths During The Abbott Investigation
Update: June 10, 2022
While the FDA was investigating Abbott, as many as nine infants died from December 1, 2021 to March 3, 2022. Although none of the DNA sequences from the FDA investigations matched Abbott’s products, all the fatalities were fed Abbott powdered formula: (31)
- Similac Advance
- Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics
- Similac Pro-Total Comfort (Powder) infant formula
- Similac Pro Advance infant formula
- EleCare infant formula
- Similac PM 60/40
Two of these infant deaths were among the four confirmed Cronobacter sakazakii infections that made Abbott recall Similac and other formulas in February. (31)
Abbott Resumes Production Of EleCare & Specialty Formulas
Update: June 6, 2022
On June 4, 2022, Abbott restarted its facility in Sturgis, Michigan, the same one that was shut down in February following the massive Similac recall. (32)
Abbott resumed production of EleCare and other specialty or metabolic formulas. These are made for babies with severe food allergies or digestive problems.
The company will also restart Similac production, as well as other formulas, as soon as possible.
Abbott clarified that these formulas are expected to reach market shelves by June 20. (32)
Although it isn’t likely to magically solve the US formula shortage, the plant’s reopening is expected to help improve supplies in the market soon.
US Formula Shortage Hits 70%, Foreign Companies Help
Update: May 31, 2022
Datasembly recently announced that the out-of-stock rates have gone to alarming levels as high as 70% across the US, that’s for the week ending May 22. (33)
After US President Biden asked government agencies to use US military planes to bring formula from overseas to help solve the shortage, a number of foreign baby formula companies announced that they will ship products to the US:
- Bubs Australia will ship at least 1.25 million cans of baby formula to the US (34)
- The makers of Kendamil, UK manufacturer Kendal Nutricare, said that it will send formulas to fill 100 trucks over the next six months (35)
Abbott Takes “Serious Steps” To Address Formula Shortage
Update: May 25, 2022
Abbott CEO Robert Ford apologizes to the public for the company’s role in the formula shortage following the massive recall of Similac, Elecare, and Alimentum products in February 2022. (36)
Considering that Abbott used to have a 40% share of the US baby formula market, the plant shutdown after the massive formula recall worsened the infant formula shortage which began in 2021. (37)
The following are the “serious steps” Abbott is taking to address the infant formula shortage: (36)
- Acceleration of production processes
- Converting production lines from adult nutrition products to ready-to-feed liquid infant formula at their facility in Columbus, Ohio
- “Rigorous inspections” of products
- A $5 million fund especially for families whose babies were hospitalized because they didn’t have access to the specialized products
- Air-shipping millions of the most widely used powdered baby formulas coming from an FDA-approved facility in Ireland
Ford also assured that once production started, they will do the following: (36)
- More than double the current production
- Invest in upgrading safety and quality processes and equipment
- Make significant investments to make sure the issue doesn’t happen again
Ford added that they issued the voluntary recall because they didn’t want to risk the babies’ lives and health. However, he clarified that none of the bacterial strains in the reported infections that killed two babies were found in Abbott’s products. (36)
He explained that the data collected in the genetic sequencing of the company’s retained product samples and the available samples from the four complaints didn’t have any connection, based on their investigation. (36)
The FDA Refutes Abbott’s Claim About The Bacterial Strains
While Abbott maintains that the bacterial strains from the FDA’s investigations didn’t match the samples from their Sturgis plant, FDA officials recently refuted this claim. (38)
According to Susan Mayne, the FDA’s food director, they were actually unable to determine a link between the Abbott products and the babies’ cases because they only had DNA sequences from two babies. (38)
They weren’t able to sample the two other babies.
Although the sampled babies didn’t have the same bacterial strains as those in Abbott’s plant, the strains of the two others remain unknown.
Abbott’s Production Resumption Needs Approval Of Court Consent Decree
According to Abbott spokesperson Jonathon Hamilton, a federal judge at the US District Court for the Western District of Michigan has signed off a legally binding agreement between Abbott Nutrition and the FDA. (39)(40)
It detailed steps they must comply with for production to resume: (39)(40)
- Cleaning and sanitizing their facility and all the equipment
- Restarting all equipment
- Doing test runs
- Checking on ingredients
- Conducting multiple tests
- Hiring an independent third party expert to review the facility’s processes
The court consent decree also requires Abbott to review and change the following: (39)
- Environmental monitoring program
- Employee training programs
- Product sampling and testing plans
Once production starts, Abbott is directed to immediately stop production and notify the FDA if they detect any contamination. (40)
Did Abbott Enrich Shareholders While The Plant Needed Repairs?
Abbott reportedly enjoyed profits as high as 94% between 2019 and 2021 even as bacteria was detected in its products during the same period. (41)
Two years before the Similac recall, Abbott’s net profits increased from $3.6 billion to $7.1 billion, according to Securities and Exchange Commission records. (41)
Then, the company allegedly increased dividends by over 25%, also offering shareholders a stock buyback program worth $5 billion. (41)
This alarmed progressive economic advocacy group, Groundwork Collaborative.
The group’s chief economist, Rakeen Mabud, pointed out that instead of improving its facilities and making productive investments, the company chose to prioritize shareholders. (41)
American Economic Liberties Project senior fellow Moe Tkacik also accused Abbott and similar companies of using consumer products as a personal ATM. She added that buybacks were supposed to be illegal until 1982 because they were considered a form of manipulation. (41)
Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbott’s case, companies whose largest customers are federal programs such as the WIC. (41)
They are calling for stricter antitrust enforcement, limits on shareholder dividends, and bans on buybacks.
Abbott Nutrition denies the allegations that its buyback program hurt the products’ safety. (41)
The company said that its “strong balance sheet” even allowed them to improve facilities while offering shareholders the stock buybacks.
Senate Plans To Investigate Abbott’s Buyback Program
The Senate Finance Committee announced that they’re investigating Abbott’s investments in their plant’s safety improvements while enjoying record revenues. (42)
Senator Ron Wyden has reportedly requested the company for information on their stock buyback program. (41)
Possible Criminal Charges Over Baby Formula Shortage
House Speaker Nancy Pelosi said that there could be an indictment after the nationwide baby formula shortage is resolved. It will prevent a similar crisis from happening again. (43)
Pelosi didn’t specify the details of the possible criminal charges and who will be included in the indictment. However, she clarified that her remarks aren’t associated with any of her colleagues. (43)
She explained that it’s more important to solve the crisis as soon as possible. It’s more urgent than an indictment. (43)
Babies Hospitalized Due To Formula Shortage
Several babies and even older children in the US have been hospitalized amid the formula shortage. Most of the kids had a medical condition that made it difficult for them to digest the proteins in regular formula.
Some of the babies relied on the amino acids (building blocks of proteins) in EleCare for nourishment because these didn’t have to be digested.
For many of these kids with medical conditions, finding the right formula can be a tedious process because the new one has to meet their nutritional needs but shouldn’t trigger potentially dangerous reactions like dehydration or diarrhea.
After the February recall, however, parents couldn’t find Elecare and similar alternatives. They had to try other formulas but the babies experienced dehydration because they couldn’t tolerate the new formula. (44)
Other babies were hospitalized due to intolerance to a new formula or for experiencing mineral imbalances after taking homemade formula.
Children’s Wisconsin warns that homemade formulas can lead to liver and/or kidney damage. These can also cause your baby’s heart to stop due to an imbalance. (45)
Jennifer Crouse, the Clinical Nutrition Manager at Children’s Wisconsin, also advised against watering down formulas because it can lead to brain swelling or organ failure. (45)
She recommends asking your baby’s pediatrician before giving them any formula substitute.
Data from different US hospitals showed several children hospitalized relating to the formula shortage:
- Three babies were admitted to the Medical University of South Carolina Shawn Jenkins Children’s Hospital in Charleston for intolerance, and another for mineral imbalance after taking homemade formula. (46)
- Two children were admitted to Le Bonheur Children’s Hospital in Memphis, Tennessee because they needed EleCare for short bowel syndrome (they couldn’t absorb full-size proteins). Their parents couldn’t find stocks. (44)
- An undisclosed number of kids (babies and older) were admitted to Children’s Healthcare of Atlanta in Georgia for malnutrition. All had specific dietary needs and were unable to tolerate new formulas. (45)(47)
- An undisclosed number of children were treated at the ER or admitted to Children’s Wisconsin for malnutrition after taking inappropriate substitutions such as homemade formula. (45)
Biden Invokes Defense Production Act
To directly address the baby formula shortage, US President Joe Biden invoked the Defense Production Act on May 18, 2022. (38)
This allows infant formula manufacturers to ramp up production because suppliers must prioritize their orders before any other customer ordering the same goods. (35)
The first Defense Production Act “priority orders” are for Abbott Nutrition (Similac) and Reckitt Benckiser (Mead-Johnson’s Enfamil). (48)
It’s expected to allow Abbott to increase their production by one-third, once the plant resumes its operations. (48)
Reckitt facilities will also operate at maximum capacity following the priority shipments. (48)
Biden Launches “Operation Fly Formula”
Biden also launched “Operation Fly Formula” to fly formulas from overseas suppliers that meet US standards using Department of Defense cargo planes to help restock shelves. (35)
Thanks to these special cargo flights, shipments that usually take two weeks can already reach the US within 72 hours. (46)
Formula Makers Import European Stocks To Help With US Shortage
Importing formulas is one of the Biden administration’s measures to help ease the ongoing shortage in the US. (49)
Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. (50)
These are products that serve a critical medical purpose because they’re for babies with cow’s milk protein allergies. The increased shipment might have been easier because both were already being imported even before the shortage. (50)
Nestle also increased production and “worked round the clock” to meet the demand. (48)
First European Shipment Arrives In The US
The first batch of specialty infant formulas (78,000 lbs) arrived in the US through “Operation Fly Formula.” (48)
According to White House National Economic Council director Brian Deese, the Air Force cargo plane carried 15% of the specialty medical-grade baby formula needed in the US.
It included 132 pallets of the following: (46)
- Nestle Health Science Alfamino Infant formulas
- Nestle Health Science Alfamino Junior formulas
These specialty formulas aren’t expected to stock up retail store shelves. Instead, they’ll be distributed by Nestle to pharmacies, hospitals, and doctor’s offices. Priority will also be given to worst-hit regions, according to a Biden administration official. (48)
This first batch can provide enough formula for one week for around 9,000 babies and 18,000 toddlers, according to Agriculture Secretary Tom Vilsack. (46)
More Formula Shipments Expected Soon
Another cargo plane carrying 114 pallets of Gerber Good Start Extensive HA formula from Europe is expected to arrive via the second flight of Operation Fly Formula in the coming days. (48)
The White House further announced that the first round of “Operation Fly Formula” flights will carry as much as 1.5 million doses of eight-ounce bottles. (46)
House Passes Emergency Bills To Address The Shortage
One bill lets WIC participants buy any formula from available suppliers instead of waiting until a WIC-approved brand becomes available. (50)(51)
The bill grants the secretary of the Department of Agriculture permanent flexibility to issue waivers during supply disruptions.
To prevent a similar formula shortage from happening again, the bill also requires manufacturers to create a contingency plan that will protect against supply disruptions in the event of a recall. (51)
The bill passed in the House with a large bipartisan majority vote. It was also approved by the Senate, and is waiting for Biden to sign it into law. (52)
However, the second bill (emergency spending bill) was received with more resistance from the Republican representatives.
The Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDA’s resources, including adding more staff who can ensure baby formula safety and improve the supply. (35)
A total of 192 Republican lawmakers voted against the bill but it was still passed by the House after getting a majority vote. (52)
Many Republicans claimed that “throwing millions of dollars at the problem won’t fix it.” (52)
- Rep. Bill Huizenga said that more formula production is needed, not more FDA staff. (35)
- Rep. Andy Harris, chair of the Appropriations subcommittee funding the FDA, claimed that it was a leadership issue, not a money problem. (51)
- Republican Conference Chair Elise Stefanik accused Biden’s “failed leadership,” saying that it’s responsible for America’s baby formula crisis. (52)
The House’s budget measure is expected to meet more resistance in the Senate because Republicans are questioning why the FDA wasn’t held accountable for the shortage. They’re also questioning the possible lapses that led to the deaths of the two babies with links to the Abbott products. (42)
Republican House representatives filed a counter bill called the “Babies Need More Formula Now Act” to obtain formulas from overseas sources. (52)
FDA Commissioner Faces Congress
During a May 2022 bipartisan hearing, FDA Commissioner Dr. Robert Califf faced Congress in an investigation of the infant formula shortage.
Rep. Rosa DeLauro and other lawmakers asked the FDA head why the agency waited several months before investigating a whistleblower complaint on alleged safety violations at Abbott’s Sturgis plant. However, Califf sidestepped these questions because he couldn’t share details of the agency’s ongoing investigation. (53)
The FDA chief admitted to reading the complaint but didn’t specify what steps were taken to immediately address the issue.
Califf announced, instead, that the company could restart production soon (possibly in a week or two) after complying with safety upgrades and certifications. (53)
Making Food Safety A Priority
Congressional leaders and various groups want to hold the FDA accountable for possible lapses or overlooked responsibilities that led to the Abbott plant shutdown and baby formula shortage.
Several groups are also calling on the FDA to restore the deputy food commissioner position (it was removed during the Trump administration). They believe that having a leader taking this position can unify and improve the FDA’s food program. (54)
The groups also want to make sure that the FDA will prioritize food safety to avoid another formula crisis in the future.
FDA Asks For More Budget
During the hearing before the House subcommittee, Califf asked lawmakers to increase the agency’s budget from last year’s $2.1 billion to $8.4 billion for food safety and nutrition. (42)
This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. (42)
Califf insisted that there’s a need for major improvements at the FDA, not because the people were bad but because they needed the right resources and consistent leadership. (53)
Why Is The Formula Market Vulnerable?
The FDA commissioner and lawmakers agreed that the US formula market is vulnerable to disruptions due to consolidation (strong market players taking over smaller competitions). (53)
To date, as much as 90% of the formula market is dominated by just four players: (53)
- Abbott (Similac)
- Reckitt Benckiser (Mead-Johnson’s Enfamil)
These four companies also dominate the WIC program contracts, which account for 50% of US formula productions. (53)
So, disruptions of these major companies’ supplies, such as a massive recall can greatly affect the formula supply in the market.
Before the massive Similac recall, Abbott Nutrition topped the formula market spot with 40% of the market share. It was closely followed by Enfamil.
However, after the Similac recall and Abbott’s plant closure, Reckitt Benckiser claims that Enfamil now takes the top spot with 50% of the market share. (55)
To meet the increased demands, Enfamil production was ramped up by 30%, the company added. (55)
Can The US Import Infant Formula From Other Countries?
Yes. However, this can be difficult because the FDA has specific nutritional standards that are different from those followed in other places, such as Canada and the European Union. (56)
Also, the US levies heavy tariffs on imported baby formula, which go as high as 17.5%. (56)
FDA Commissioner Robert Califf announced that they’re “loosening” restrictions on imported baby formulas to “efficiently and safely” improve the US supply. (56)
However, the FDA’s published guidance continues to require brands to meet the minimum requirements for nutrients, labeling, and safety tests. (57)
FDA Reportedly Continues To Seize European Baby Formula Amid Shortage
Although the FDA announced that it will streamline regulatory approvals for imported formulas, there are some reports of the federal agency cracking down on sellers offering these products. (58)
Some American parents claimed that European formulas they ordered directly from Europe were seized and destroyed by US customs agents. (58)
In defense, the FDA explained that European formulas don’t meet the agency’s requirements because these: (58)
- Require less water per scoop than US formulas
- Might need different temperature conditions for storage
- Don’t meet FDA labeling requirements in terms of specific labeling on iron content, formula-preparation instructions in English, or instructions on how to store the product
- Don’t have a system to notify US consumers of recalls
However, many parents point out that even if major European producers like Hipp and Holle don’t comply with FDA regulations, they comply with European regulatory authorities, making them still safe for babies to consume. (58)
Most of the products meet FDA-required nutrient levels, although some don’t contain iron levels that meet the FDA’s minimum requirements.
Still, these European formulas could help ease the formula shortage for many desperate US parents.
They hope that the FDA can instead find another approach instead of destroying precious formulas.
Many American parents are hoping that the federal agency will help make these options safer by doing the following: (58)
- Coordinate with European regulatory authorities on recalls
- Provide English-language instructions (already offered by some European formula importers)
- Explain European health and safety standards
- Convert to American-size scoops
AAP Lowers Age Recommendation For Cow’s Milk
Amid the formula shortage, a recent AAP (American Academy of Pediatrics) FAQ showed a much lower age recommendation for cow’s milk from one year old to six months of age. (59)
Pediatrician: Cow’s Milk Can Be Better Than Homemade Formula
The division chief for Pediatrics at Spectrum Health, Dr. Hanna Jaworski, explained that although it has its risks (e.g., increased likelihood of anemia), cow’s milk can be a better option than homemade or watered-down formula. (60)
Jaworski recommends choosing cow’s milk but only as a “bridge” for a day or two until you can find your preferred formula. (60)
She also recommends keeping it at 24 oz or less and providing your baby with their formula or a close alternative as soon as possible. (60)
She warns that cow’s milk should never be considered (even as a temporary substitute) for babies with special health needs or those using specialty formulas for allergies.
Another Pediatrician: Only Use Cow’s Milk As A Last Resort
However, Bronson Methodist Hospital pediatrician Dr. Megan Sikkema disagrees and warns parents against following the AAP’s new recommendation. She said that it should only be used as a last resort. (60)
She added that if you can’t help but give your baby cow’s milk, make sure it’s just for as short as possible. Once you find some formula, immediately switch back.
Harmful DIY Baby Formula Recipes Go Viral
The FDA advises parents against making homemade baby formula because it could be dangerous and lack vital nutrients needed to support their baby’s growth.
One baby has already been hospitalized because of mineral imbalances from taking homemade formula. (46)
What’s alarming is that harmful DIY baby formula recipes have gone viral, according to a Bloomberg report. It could be due to desperate parents searching for alternatives amid the formula shortage. (61)(62)
According to the report, Twitter posts about homemade baby formula rose as much as 2,100% (around 5,000 tweets) from the first to the second week of May. (62)
Some social media platforms removed or labeled these baby formula recipes after getting called out in the Bloomberg report. (61)(62)
Bloomberg was able to get several YouTube and TikTok videos removed.
Under its Harmful & Dangerous policies, YouTube also removed additional content that sells, promotes, or provides instruction for making homemade baby formula. (62)
Meta, Facebook’s parent company, used external content reviewers to add warning labels on the posts containing baby formula misinformation. (62)
However, Twitter didn’t consider the posts a breach of their misinformation policy. Instead, they told the outlet that they’ll review their practices “over time.” (62)
Scammers Take Advantage Of Formula Shortage
Amid the formula shortage, the FTC (Federal Trade Commission) discovered many scammers taking advantage of the situation because many desperate parents were willing to pay hefty prices just to find formulas for their babies. (63)
Many unsuspecting customers paid for the products from legitimate-looking but fraudulent online stores, but their order never arrived. It turned out that these scammers simply copied the brands’ logos to create realistic social media accounts or websites. (63)
FTC Tips To Avoid Getting Scammed
These are the FTC’s recommendations so you can avoid getting scammed: (63)
- Research about the company.
- Know your rights, especially about shipments and refunds.
- Use a search engine to check the company, brand, or product with terms like “scam,” “complaint,” or “review.”
- Don’t pay using money transfer, gift cards, or cryptocurrency.
- Use a credit card to pay. Most offer buyer protection so you can process a refund if your order doesn’t arrive.
- Check for local resources (your pediatrician or local WIC office) if they might have available stocks.
Abbott Nutrition Releases On-hold Baby Formulas Amid Shortage
Update: May 4, 2022
According to Abbott Nutrition, the FDA requested the company to release specialty and metabolic nutrition formulas, which were put on hold during the February 2022 recall. (64)
These products are used by babies in hospitals and those who need special dietary considerations.
Aside from fulfilling the FDA’s request, Abbott also announced that they’re releasing these metabolic nutrition formulas to patients for free.
Because stocks are limited (Abbott hasn’t resumed production), the items are only available on a need or case-by-case basis. The company explained that the release will be coordinated with pediatricians or healthcare professionals. (64)
Abbott assures worried consumers that these products were made before the recall but had been tested. They should comply with the release requirements before these items can be distributed. (64)
Specialty and metabolic nutrition products for release: (64)
- Calcilo XD
- Cyclinex-1 and 2
- Glutarex-1 and 2
- Hominex-1 and 2
- I-Valex-1 and 2
- Ketonex-1 and 2
- Phenex-1 and 2
- Propimex-1 and 2
- Similac PM 60/40
- Tyrex-1 and 2
The specialty formula Similac PM 60/40 (also recalled in February) is on this list because only one lot had been included. The stocks scheduled for release are from the other lots. (64)
Abbott also assured consumers that the main formulas (Similac, Alimentum, and EleCare) recalled in February 2022 won’t be included in this release. (64)
The Sturgis plant isn’t reopening yet.
Although Abbott’s reopening might help with the formula shortage, the company clarified that they’re still working with the FDA to take corrective actions at the plant and address the current situation before production resumes. (64)
Once production resumes, however, Abbott explained it could take around 6-8 weeks before these baby formula products become available for distribution.
Biden Administration Releases Measures For Formula Shortage
Update: May 13, 2022
US President Joe Biden met with retailers and baby formula manufacturers, particularly Gerber, Reckitt, Walmart, and Target, to discuss measures to help address the shortage while ensuring that formulas reach store stores safely. (49)
The White House released these measures that the Biden administration plans to follow for an increase in the number of formula products in the market, but without compromising babies’ safety: (49)
Cracking Down On Illegal Sellers For Unfair Market Practices & Price Gouging
Amid the formula shortage, some unscrupulous retailers or individuals bought dozens of formulas from legitimate suppliers but marked them up to several times the actual price for online retail to desperate parents. (49)
Some formulas normally sold for $43 to $47 are offered on eBay and other online sites for as high as $800. (65)
To avoid hoarding, retailers like CVS, Walmart, and Target have put a cap on the quantity that consumers can buy. However, they’re still running out of baby formulas despite these measures. (65)
President Biden asked the FTC (Federal Trade Commission) to crack down on these illegal sellers and use all its available tools for identifying, investigating, and monitoring these people for predatory conduct, unfair market practices, and price gouging. (49)
Increasing Supply Through Imports
The US typically produces around 98% or nearly all of the baby formulas it needs. However, the baby formula shortage started in 2021 due to supply chain issues and was worsened by the recent Similac recalls. (49)
To help keep up with the lower supplies and higher demands, the White House announced plans to increase imports from key suppliers, including the Netherlands, Chile, Mexico, and Ireland. (49)
Cutting The Red Tape
According to the White House, as many as 50% of the formula manufacturers’ production goes to the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). (49)
To meet varying demands, particularly WIC conditions, manufacturers produce different formula sizes even with the same type.
The White House believes that if manufacturers focus on simplifying product offerings, then they might increase production.
Aside from this measure, the USDA (United States Department of Agriculture) is coordinating with different states to let WIC recipients buy available products (instead of only buying WIC-approved options). (49)
Abbott Plans To Reopen Sturgis Plant Involved In Recall
The formula out-of-stock rates have soared to 43% in the first week of May, and the FDA said that it’s working with manufacturers to increase the supplies. (66)
On May 12, 2022, the CDC (Centers for Disease Control and Prevention) closed its investigation of the Abbott Nutrition products linked to the Cronobacter infections after no additional cases have been identified. (67)
However, the recall is still in effect. It’s only the investigation that’s closed.
The FDA has also established an IMG (Incident Management Group) to help address the food safety and supply chain issues that are worsening the formula shortage. (67)
It is believed that Abbott Nutrition’s reopening of its Sturgis, Michigan plant, the one involved in the massive Similac recall in February 2022, might boost the stocks. (68)
Abbott Nutrition announced that production could restart in about two weeks (or by the end of May), subject to FDA approval. (68)
However, Abbott Nutrition estimates that it could take six to eight weeks before these formula products hit the shelves from the Sturgis plant’s reopening.
To assure worried customers, Abbott Nutrition explained that they had improved their systems and protocols at the Sturgis facility.
These improvements include the following: (68)
- Updating their training, education, and safety procedures applicable for employees and visitors
- Updating protocols for cleaning, water, and maintenance procedures
- Upgrading the plant, including installation of sanitary, easily cleanable, and nonporous floors
What To Do If Your Baby’s Formula Or Food Is Recalled
In most recalls, the companies usually provide affected customers with the exact product name, the lot code or batch number, the expiration or “best before” date, or other important information about recalled items.
If you’ve heard about any baby food or formula recall, make sure to do the following:
- Double-check if your baby’s formula or food is included in the recalled products by finding the lot codes and “best before” or expiration dates usually printed at the bottom of the package.
- If the lot codes are too numerous to post, as in the case of massive recalls involving millions of products, the brand or company might not be able to provide a list immediately. If that’s the case, you can check the company’s recall advisory for a link to the site where you can search for your product’s lot code. You can also call the company for confirmation.
- Immediately stop giving any recalled products to your baby, especially items that involve possible contamination. You can discard these items or bring them back to the store for a refund.
- Never feed your baby with any recalled products, even if the packaging or contents look alright. The pathogens or other contaminants might be too small to be seen, but they can cause serious illness to your baby.
- You should contact the store or company to process the refund if your product is included in the recall. Note that some manufacturers or stores don’t require you to return the contaminated products. But they might require a receipt so you can get a full refund or product replacement.
Formulas With No Recalls Issued
These formulas haven’t been recalled:
- Similac Pro-Advance Non-GMO Infant Formula with Iron
- Earth’s Best Non-GMO Soy-Based Infant Powder Formula
- Kabrita Goat Milk Toddler Formula Powder
- Else Plant-Based Complete Nutrition for Toddlers
- Happy Baby Organics Infant Formula
- Enfamil Neuropro
- Enfamil A2 with Prebiotics
- Enfamil Enspire Baby Formula with Iron
- Meyenberg Whole Powdered Goat Milk (Gluten-Free)
Make sure to always check with your child’s pediatrician before starting or switching formulas.
What Formulas Are Being Recalled?
The following are the baby formula recalls from well-known brands in the US and worldwide.
- On February 17, 2022, Abbott Nutrition recalled Similac, Alimentum, and EleCare powdered baby formulas due to possible contamination with bacterial strains, specifically Cronobacter sakazakii and Salmonella. (69)
- Just days later, on February 28, 2022, Abbott Nutrition announced an additional recall on Similac PM 60/40 following the death of a second infant linked to this formula. These recalls worsened the formula shortage. (70)
- On January 7, 2022, the FDA issued the “Healthy Beauty” Angel Formula recall for the brand’s failure to meet the safety requirements for infant formulas, including premarket notifications and having higher levels of iron, potassium, and sodium than the maximum limits. (71)
- Able Groupe recalled all HiPP, Holle, Kendamil, and Lebenswert formulas in August 2021 for not meeting FDA requirements on pre-market notifications and iron content. (72)
- Designed by Nature recalled its formulas in June 2021 because the labels didn’t indicate that these products aren’t meant for use as baby formula. (73)
- In 2018, CVS recalled all Enfamil formulas due to a possible tampering issue. One mom complained about buying a formula that had flour inside. (74)
- In 2011, several retailers recalled Enfamil Newborn over reports that it may have caused the death of an infant due to Cronobacter sakazakii. (75)
- Is the Similac formula being recalled? In 2010, several Similac infant formula products were recalled for possible contamination with the small common beetle. (76)
- Similac Special Care was recalled in 2007 for low iron content. (77)
- Enfamil Gentlease was recalled in 2006 due to the possibility that it might contain metal particles. (78)
- Several Similac products were recalled in 2006 due to a manufacturing defect that may cause them to have lower vitamin C content. (79)
- In 2005, Similac Advance with Iron was recalled for possible contamination with black polyvinyl chloride plastic particles. (77)
- EnfaCare LIPIL was recalled in 2004 over possible contamination with Enterobacter sakazakii. (80)
- Is there a recall on Enfamil? Enfamil Nutramigen was recalled in 2001 over incorrect preparation instructions written in Spanish. The incorrect instructions may lead to serious health problems or possibly even death. (81)