Infant Formula Recalled for Lack of Premarket Safety Evaluation
Farmalac 0-12 Low lactose powdered infant formula is being recalled because the manufacturer did not submit required premarket notification to the FDA. The product has not been evaluated against U.S. food safety and nutritional standards.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for an unapproved product that has not been evaluated for food safety and nutritional standards. Although no illnesses or injuries are reported, the agency's Class I designation requires a minimum score of 4, elevated by the product's intended use for infants.
Plain-English summary
Dairy Manufacturers, Inc is recalling 5,376 cans of Farmalac 0-12 Low lactose powdered infant formula with iron (12.4 oz cans) distributed throughout Texas. The recall is being issued because the manufacturer did not submit the required premarket notification to the FDA.
Because premarket notification was not submitted, the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Parents and caregivers should not feed these products to infants and should speak with a healthcare provider about alternative feeding options.
The recalled product
- Product
- Farmalac 0-12 Low lactose powdered infant formula with iron 12.4 oz cans
- Manufacturer
- Dairy Manufacturers, Inc
- Category
- Food — Infant Formula
- Affected units
- 5,376
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 24 044 1 FBLE 352-1 02/13/2024 AUG/2025 24 068 1 FBLE 352-1 03/08/2024 SEP/2025
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Dairy Manufacturers, Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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