The Recall Desk
SevereFDA (Food)·F-1463-2024·Announced 2024-07-17

Powdered infant formula recalled for missing safety evaluation

Farmalac powdered infant formula was recalled because the manufacturer failed to submit required premarket notification to the FDA. The product was never evaluated for safety or nutritional standards.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity of Severe per the rubric. The product is unevaluated infant formula intended for vulnerable infants. No illnesses or injuries are mentioned in the recall notice.

Plain-English summary

Farmalac powdered infant formula with iron in 12.4 oz cans is being recalled because Dairy Manufacturers, Inc. did not submit the required premarket notification to the FDA. The FDA classifies this as a Class I recall—the most serious regulatory category. Parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.

The recalled product was distributed throughout Texas. Approximately 5,376 cans are affected. The batch codes are: Farmalac 0-12 24 040 1 FBE 352-1 (expiration 08/2025) and Farmalac 0-12 24 068 1 FBE 352-1 (expiration 09/2025).

Consumers who have purchased this formula should stop using it immediately and consult with a pediatrician or healthcare provider about alternative feeding options. Do not give this product to infants.

The recalled product

Product
Farmalac powdered infant formula with iron 12.4 oz cans
Manufacturer
Dairy Manufacturers, Inc
Category
Food — Infant Formula
Hazard
  • regulatory-non-compliance
  • unevaluated-product

Distribution

Distribution scope not specified by the agency.

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