In June 2019, the FDA (Food and Drug Administration) recalled the Bobbie Milk-Based Powder Companion Formula (manufactured in Germany and imported to the US) due to inadequate nutrient levels and not meeting the federal agency’s requirements. (1)
The FDA has since terminated this safety recall in April 2020. (1)
What led to the 2019 Bobbie formula recall, and how did the brand recover from it? Do the brand’s formulas now have FDA approval?
Where are they manufactured, and how do you know they’re safe for your baby?
What other baby formula brands do we recommend?
Find answers below.
Bobbie Formula Recall 2019
What Bobbie Formula Was Recalled?
In May 2019 the FDA announced the recall of several lots of Bobbie Milk-Based Powder Companion Formula, 14.1 oz (400 g), manufactured in Germany and shipped to the US. (1)
Affected lots: (1)
- L6236501Z001; Use By: 9.15.2020
- L6236501Z002; Use By: 9.15.2020
- L6236501Z003; Use By: 9.16.2020
- L6236501Z004; Use By: 9.16.2020
These recalled products were sold in the San Francisco Bay Area of California. (1)
Why Was The Bobbie Formula Recalled?
As shown on the packaging, the product’s iron content is only 0.7 mg per serving. This is lower than the FDA’s minimum requirement of 1 mg per 100 kcal. (1)
Adequate nutrient levels, especially iron, are important for babies’ healthy development. This is especially a big concern for babies with low birth weight, born prematurely, or are at risk of becoming iron deficient because of an illness. (1)
Human bodies don’t produce iron. If babies continue receiving inadequate iron levels from their formula, they can suffer from iron-deficiency anemia unless they’re provided with iron supplementation. (1)(2)
Because iron is essential for moving oxygen from the lungs to other parts of the body, including the brain, iron deficiency can be a serious health concern. (2)
Iron deficiency anemia can affect the child’s growth and development if left untreated. (2)
Symptoms of iron deficiency include the following: (2)
- Cold hands and feet
- Pale skin
- Slowed growth and development
- Poor appetite
- Abnormally rapid breathing
- Frequent infections
- Behavioral problems
- Unusual cravings for non-nutritive items (e.g., dirt, paint, ice, or starch)
Aside from low iron content, the European-made Bobbie formula was also recalled due to the lack of labeling about these nutrients required by the FDA in infant formula: (1)
- Linoleic acid
- Pantothenic acid
- Vitamin B6
- Vitamin C
- Vitamin K
These are considered key nutrients in baby formula. Inadequate levels can lead to nutrient deficiencies, poor growth, and/or serious health issues for developing babies. (1)
It’s common for European formulas to have different nutrient levels than US formulas because they follow different standards and requirements.
However, the FDA requires that all formulas sold and used in the US must meet their requirements. (3)
Also, products with inadequate nutrient contents must indicate this on the packaging, noting that supplementation might be necessary. (3)
The affected Bobbie products have been removed from the formula market, and the consumers were informed about it. (1)
While the recall was a big blow to the startup, it paved the way for the brand to improve and become the first European-style brand manufactured in the US and regulated by the FDA.
How Is Bobbie Formula Today?
Is Bobbie Formula Safe For Babies?
Yes. The new formula, currently manufactured in the US, is an improvement of the old product previously made in Europe.
Bobbie currently has two formula products:
- Bobbie Organic Infant Formula
- Bobbie Organic Gentle Infant Formula
Both have 1.2 mg of iron per 100 kcal, meeting US (FDA) and EU standards.
They’re also USDA Organic certified (United States Department of Agriculture) and made with milk from grass-fed cows.
Like other European brands, these Bobbie formulas use lactose as the main carbohydrate, and are free from corn syrup, an added sugar that can promote obesity and increase appetite. (4)
Although formulated safe for newborns and babies up to 12 months old, be sure to consult your pediatrician before giving any formula to your little one.
Read our in-depth Bobbie Formula review for more information about these products.
Who Makes Bobbie Formulas?
This formula brand was founded by Laura Modi as Bobbie Baby, LLC, in 2018, from her San Francisco, California home.
An AirBNB operator at the time, Modi conceptualized the company after having difficulty finding a healthy baby formula for her eldest child. (5)
She was saddened by the questionable ingredients, like corn syrup, in most formulas on the market. (5)
Modi’s cofounder and AirBNB “work wife” Sarah Hardy joined the company in 2019. (5)
Although Bobbie began as a European brand sold in the black market along with many other formulas from Europe, it’s now a top-selling American-made baby formula manufactured by Perrigo facilities in Ohio and Vermont.
Is Bobbie Baby Formula FDA-Regulated?
US-made Bobbie Formula was green-lighted by the FDA in August 2020, just a year after the German-made powder formula was recalled.
How Did Bobbie Formula Fix The Problem & Become FDA-Regulated?
The cofounders collaborated with scientists and pediatric nutritionists to create a European-style formula that meets the FDA’s regulatory requirements.
Does The FDA Approve Baby Formulas?
Infant formula manufacturers don’t need the FDA’s approval before they can produce or market their products. (3)
However, they must still meet the regulatory standards, and the FDA’s labeling requirements, or their products might be recalled. (3)
The federal agency has been regulating baby formulas since 1980 under the Infant Formula Act. (3)
The FDA regulates infant formulas to ensure they’re safe and nutritious, but recently have been under criticism and fire for failing to prevent the big formula shortage of 2020 following major recalls.
FDA Requirements For Infant Formulas
Some of the FDA’s nutrient specifications (amount per 100 kcal of baby formula): (6)
- Protein: 1.8 g to 4.5 g
- Iron: ≥0.15 mg
- Calcium: ≥ 60 mg
- Iodine: 5 mcg to 75 mcg
- Fats: 3.3 g to 6.0 g (≥ 30% of calories)
- Folic acid (folacin): ≥4 mcg
- Magnesium: ≥6 mg
Find the full list of these requirements and Bobbie’s nutrient contents in our Bobbie Formula review.
Bobbie Formulas & Perrigo
Bobbie partners with Perrigo Nutritionals for infant formula production. The private label manufacturer makes cost-effective baby formula products for store brands like Parent’s Choice at Walmart, Well Beginnings at Walgreens, and Love & Care at Amazon.
Are Perrigo Facilities Safe?
Yes. Perrigo complies with the Safe Quality Food (SQF) Code and meets FDA standards.
The company has been in the industry since 1998 and is the third-largest infant formula manufacturer supplying products to US and Canadian markets.
Where Are Bobbie Formulas Manufactured?
How Does Bobbie Keep Their Formulas Safe?
2,000+ Tests & Formula Sampling Per Batch
According to Bobbie, each batch undergoes 2,000+ safety tests to ensure products are safe before they hit the infant formula market.
Does Bobbie Have Pesticides?
No. Bobbie has Clean Label Project Pesticide-Free Certification.
Are There Heavy Metals In Bobbie Formulas?
No. Bobbie also has the Clean Label Project Purity Award.
Lot Code Tracker For Customers
Anyone can check the batch’s safety tests using Bobbie’s unique lot code tracker (hibobbie.com/pages/safety).
Active Complaint Reviews
The brand also assures consumers that they’re actively reviewing and addressing complaints.
Tamper-Evident Cans For Added Security
Bobbie uses tamper-evident cans to assure subscribers that their products are safe on their journey across the supply chain. You’ll know if the product has been tampered with.
Bobbie offers formula subscriptions so consumers don’t have to worry about heading out to find the product for their babies.
Bobbie During The Infant Formula Shortage
Bobbie’s formula subscription has been especially helpful to subscribers during the baby formula shortage.
The brand temporarily stopped accepting new subscriptions to ensure their subscribers always had baby formulas when needed.
During the shortage, the brand also expanded to retail, selling in Target stores nationwide.
Bobbie takes pride in being the only US baby formula brand to expand to retail during the formula crisis.
Are Bobbie Customers Informed Of Any Recalls?
Yes. Bobbie assures subscribers that they will be informed if the brand issues any recalls.
During the product recall in 2019, Bobbie’s cofounders contacted their customers to inform them about the safety issue.
The Latest Bobbie Formula Recall Updates & Warnings
Infant Formula Manufacturers Received FDA Warning Letters
Update: August 31, 2023
The FDA issued three infant formula manufacturers warning letters over undisclosed inspection findings done in the last several months: (10)
- Perrigo Wisconsin, LLC
- ByHeart Inc.
- Mead Johnson Nutrition (Reckitt)
The federal agency did the inspections to help reduce the risks of another formula shortage, but no recalls were issued over these recent warnings. (10)
Perrigo makes Bobbie infant formulas. However, the names of the affected Perrigo-manufactured formula brands weren’t stated in the FDA warning letter.
Our Top Baby Formula Recommendations
- Bobbie Organic Infant Formula
- Serenity Kids A2 Toddler Formula (Use our code MHC for 15% off first-time orders, too!)
- ByHeart Baby Formula
- Holle Organic (Bio)
- Hipp Dutch Combiotic Formula
What Does It Mean To Recall A Formula?
As explained above, formulas must meet the FDA’s labeling and nutrient requirements. Any formula that doesn’t meet these standards can be recalled at anytime.
The products also lacked proper labeling that should have warned parents their babies might need supplementation because the formula has inadequate iron levels. (7)
Some baby formulas are sometimes recalled because they exceed the FDA’s maximum limits. Although rare, this happened to the Angel Formula recall. (8)
Although we might think more nutrients are better, too much can also be harmful. It can lead to iron overload or a nutrient imbalance that can also affect the body’s organs. (8)
Aside from nutritional standards, the FDA and manufacturers can also issue baby formula recalls whenever there are possibilities or reports of potential contamination.
For example, the FDA and Abbott Nutrition recalled Similac products after receiving reports of infant deaths and hospitalizations linked to formulas produced by the brand’s Sturgis, Michigan facility. (9)
How Do You Check If A Formula Has Been Recalled?
The FDA’s website (fda.gov) is the best source of information for baby formula recalls.
You can stay informed about the latest recalls or other news on baby formula and other product recalls by signing up for our regular Motherhood Community recall alerts.
Formula Recalls To Monitor
- Gerber Good Start SootheProTM Powdered Infant Formula (2023)
- Enfamil ProSobee Simply Plant-Based Infant Formula (2023)
- ByHeart Whole Nutrition Infant Formula (2022)
- Similac recall (2022)
- Alimentum (2022)
- EleCare (2022)
- Angel formula recall (2022)
- Able Groupe formula recall (2021) for Holle, HiPP, Kendamil, and Bioland (Lebenswert)
- Parent’s Choice Advantage infant formula recall (2019)
- Nutricia KetoCal 3:1 (2022) – not a recall, only a safety alert for Cronobacter
Other Recent Baby Product Recalls & Safety Warnings
Check these comprehensive lists of product recalls by category:
- Stroller recalls (2020 to 2023)
- Recalled toys list (2020 to 2023)
- Baby formula recall (2001 to 2022)
- Baby food recall (2015 to 2022)
- Pacifier recall (2019 to 2022)
- Baby wipes recall (2014 to 2022)
Other individual product recalls:
- Walker Edison bunk bed recall (2023)
- Sakar’s Tony Hawk helmet recall (2023)
- Kindred Bravely bamboo nursing hoodie recall (2023)
- Cybex recall (2023)
- Patagonia recall (2023)
- Safety 1st recall (2023)
- Maxi Cosi recall (2023)
- Lancaster high chair recall (2023)
- Fabuloso cleaning products recall (2023)
- PJ Salvage pajamas (2023)
- Target blanket recall (2022)
- Crate & Barrel crib recall (2022)
- Laundress recall (2022)
- Bentex children’s clothing recall (2022)
- Otteroo infant flotation ring safety warning (2022)
- Green Sprouts sippy cup recall (2022)
- Parent’s Choice wipes removal from shelves (2022)
- Toddleroo cabinet latch recall (2022)
- 4moms Rockaroo recall (2022)
- NUK glass bottle recall (2022)
- BIBS bottle recall (2022)
- Winter Water Factory baby clothes recall (2022)
- Babyganics bubble bath product recall (2022)
- Frigg pacifier recall (2022)
- Maxi Cosi Pria 85 recall (2021)
Other Baby Formula Articles & Guides
- Can You Mix Breast Milk & Formula?
- Serenity Kids’ Toddler Formula
- FDA Announces Infant Formula Study
- Formula Companies Possibly Exploiting Parents’ Fears For Profits
- The Best Baby Bottles
- The Best Formula Dispensers
- Travel Formula Dispensers
- How To Sanitize Baby Bottles