The Recall Desk
SevereFDA (Food)·F-1465-2024·Announced 2024-07-17

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.

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 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
Hazard
  • unapproved-product
  • not-evaluated-for-safety

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

Distribution scope not specified by the agency.

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