Minnesota Milk Bank Donor Human Milk Recalled for Undetermined Foreign Material
Minnesota Milk Bank for Babies is recalling 136 bottles of pasteurized donor human milk due to potential contamination with undetermined foreign material. The affected batch (002237-1) expires 01/01/2025.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a high-risk product for infants. Foreign material in infant milk presents an aspiration or choking hazard. Although no illnesses have been reported, the risk-of-harm classification combined with the vulnerable infant population justifies High severity per the rubric criterion.
Plain-English summary
Minnesota Milk Bank for Babies, located in Roseville, Minnesota, is recalling 136 bottles of pasteurized donor human milk (4 fl oz / 120 ml bottles, 20 kcal/oz, 1.0 g/dL total protein) due to contamination with undetermined foreign material.
The recall was issued by the FDA as a Class II recall. The specific nature and composition of the foreign material have not been determined. The affected batch is 002237-1 with an expiration date of 01/01/2025.
The recalled product was distributed in Minnesota. Consumers who have purchased this product should not use it. Contact Minnesota Milk Bank for Babies directly for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- MN Milk Bank for Babies Pasteurize Donor Human Milk. Volume: 4 fl. oz. / 120 ml. Milk Type: 20 kcal/oz. 1.0 g/dL Total Protein. MN Milk Bank for Babies, Roseville, MN 55113
- Manufacturer
- Minnesota Milk Bank for Babies
- Category
- Food — Infant Nutrition
- Hazard
- Affected units
- 136
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)
- Batch 002237-1 Exp Date: 01/01/2025
Distribution
Distributed in 1 state:
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