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Baby formula recalls

FDA enforcement records (2012+) and announcements (Oct 2017+) for infant formula.

Two official FDA feeds, merged: the machine-readable enforcement database (FDA-classified recalls, 2012+) searched for infant/baby/toddler formula, and FDA's Recalls & Safety Alerts announcements (October 2017+) matching formula terms or the major formula brands. A recall usually appears first as an announcement and later as classified enforcement entries.

Brand pages: Similac · Enfamil · Gerber · Nutramigen

FDA enforcement events mentioning formula (2012–present)

PostedFirmProductReasonClass
NARA ORGANICS INCa.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with…Product may be contaminated with Clostridium botulinum.Class I
The a2 Milk Companya2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g)…Possible contamination with Cereulide toxin.Class I
Valley Springs Artesian Gold, LLCValley Springs 100% Natural Bottled Water packaged in the following size plastic jug…Water was bottled under insanitary conditions.Class II
ByHeart, INC.1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack,…Contaminated with Clostridium botulinumClass I
PBM Nutritionals, LLCCVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based…Product contains levels of Vitamin D above the maximum level permitted.Class II
Dairy Manufacturers, IncCrecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans (+2)The firm has not submitted the required premarket notification, parents and caregivers should…Class I
Graceleigh, Inc. dba Sammy's MilkSammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak (+1)FDA inspection and investigation of firm's website and social media pages found that Sammy's online…Class I
Mead Johnson & Company LLCEnfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and…Product has the potential to be contaminated with Cronobacter sakazakii.Class I
The Little Oak Company LtdLittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g… (+1)No pre-market notification and Mixing instructions not in ouncesClass II
PBM Nutritionals, LLCParent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic…Inadvertent release of rejected product to marketClass III
Nutricia North AmericaTYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186…Infant formula contains undeclared tyrosineClass II
Perrigo NutritionalsGerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1,…Infant Formula has the potential to be contaminated with Cronobacter spp.Class I
ByHeart, INC.By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 gInfant formula potentially contaminated with Cronobacter sakazakiiClass I
Abbott LaboratoriesAbbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar,… (+21)Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence…Class I
SunOpta Grains and Foods Inc.Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons…Product that did not meet quality standards was released in error. Complaints of spoilage received.Class II
Able Groupe IncLebenswert Folgemilch Stage 3 Organic Toddler FormulaThe required pre-market notifications for these new infant formulas have not been submitted to the…Class II
Abbott Nutrition, Division of Abbott…Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1…Water filled bottles labeled as Similac Pro-Advance.Class III
Abbott LaboratoriesAbbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a…Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal…Class II
Perrigo Company PLCParent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g,…Product may contain metal fragments.Class II
Abbott LaboratoriesSimilac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic…The firm received three consumer calls of product with Chinese labeling. After an internal…Class II

Formula-related FDA announcements (Oct 2017–present)

DateBrand / productReasonLink
Nara Organics — Whole Milk Powdered Infant FormulaPotential risk of Clostridium botulinum contamination.Notice
a2 — a2 Platinum Premium Infant Formula 0-12 months USA labelPresence of cereulide toxin produced by some strains of the bacterium Bacillus…Notice
ByHeart — Whole Nutrition Infant formula 24 oz cans and 0.6oz packetsPotential Foodborne Illness – Clostridium botulinumNotice
ByHeart — Whole Nutrition Infant formulaPotential Foodborne Illness – Clostridium botulinumNotice
CVS Health, H-E-B Baby — Premium Infant Formula with Iron Milk-Based PowderProduct contains levels of Vitamin D above the maximum level permittedNotice
Crecelac — Powdered Goat Milk Infant FormulaCronobacter spp. contaminationNotice
Crecelac and Farmalac — Infant FormulaFood Compliance Programs – Baby FormulaNotice
Sammy’s Milk — Goat Milk Toddler FormulaProduct does not provide sufficient nutrition when used as an infant formulaNotice
Enfamil — Nutramigen Powder infant formula in 12.6 and 19.8oz cansPotential Cronobacter sakazakii contaminationNotice
Gerber Good Start — Powdered Infant formulaPotential Cronobacter sakazakii contaminationNotice
ByHeart — Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12monthsPotential for cross-contamination with Cronobacter sakazakiiNotice
Similac, Alimentum, and EleCare — Powder Infant FormulaConsumer complaints regarding Cronobacter sakazakii, Salmonella Newport.Notice
Moor Herbs — Angel Formula Infant formulaProduct did not meet specific nutrition and labeling requirements for infant…Notice

Download: baby-formula-recalls.csv (CSV, updated nightly).

Related: all FDA food recalls · pet food recalls