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.
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 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
- Affected units
- 5,376
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Dairy Manufacturers, Inc
See all →- CriticalCrecelac Infant Powdered Formula Recalled Due to Cronobacter
FDA (Food) · 2024-07-17
- SevereInfant Formula Recalled for Lack of Premarket Safety Evaluation
FDA (Food) · 2024-07-17
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
Similar recalls
- SeverePerrigo Recalls Parent's Choice Infant Formula Due to Metal Fragments
FDA (Food) · 2019-07-24
- ModerateAbbott Recalls Water Bottles Labeled as Similac Pro-Advance Infant Formula
FDA (Food) · 2020-07-22
- ModerateSimilac Advance Infant Formula Recalled for Chinese Labeling
FDA (Food) · 2015-03-18
- HighTYR Anamix Early Years infant formula recalled for undeclared tyrosine
FDA (Food) · 2023-06-28
- Severea2 Platinum infant formula may be contaminated with cereulide toxin
FDA (Food) · 2026-06-10
- HighSimilac 360 infant formula recalled for compromised seal integrity
FDA (Food) · 2022-11-23