The Minnesota Milk Bank for Babies has issued a recall of 136 bottles of pasteurized breast milk over concerns they may be contaminated with foreign material, according to the Food and Drug Administration (FDA). The affected products, distributed exclusively within Minnesota, were recalled in December 2024.
The specific source of the contamination has not been identified. However, the FDA has classified the recall as a Class II risk, which pertains to products that “may cause temporary or medically reversible adverse health consequences,” although the probability of serious harm is considered low.
Why This Matters
The recall is especially significant because infants are highly vulnerable to contamination, and exposure to unsterilized products or foreign materials could pose health risks. The FDA’s Class II risk classification suggests that while the issue is concerning, serious health consequences are unlikely.
Details of the Recall
The recall involves pasteurized donor human milk, with each bottle containing 4 fl. oz. (120 ml) of milk and a nutritional value of 20 kcal/oz. The product is marked with an expiration date of January 1, 2025.
The Minnesota Milk Bank voluntarily initiated the recall on December 3, 2024. On January 2, 2025, the FDA confirmed the risk classification for the affected bottles. The FDA employs three risk classifications for recalls:
- Class I: Products that could cause serious health consequences or death.
- Class II: Products that may cause temporary or reversible adverse health effects, with low probability of serious consequences.
- Class III: Products unlikely to cause any adverse health effects.
What the Minnesota Milk Bank Says
While the Minnesota Milk Bank for Babies has not yet commented publicly on the recall, the organization emphasizes its commitment to ensuring the safety of its donor milk. On its website, the Milk Bank states its mission to improve infant health outcomes, especially for medically vulnerable babies in Minnesota and the Upper Midwest. The organization stresses its adherence to “strict standards for donations and processing.”
Next Steps
According to the FDA, the recall has been completed. The agency advises consumers who believe they may have experienced an adverse reaction to the recalled product to report it through the FDA’s website.
For now, the recall highlights the importance of stringent safety measures in the handling of donor milk to protect the health of vulnerable infants.
