Pasteurized donor human milk bottles have plastic particulate under the cap
Pasteurized Donor Human Milk in 4 oz bottles is being recalled because plastic particulate from the outer closure was found between the foil seal and the plastic cap. 209 bottles are affected.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall where the particulate sits outside the sealed product, between the foil seal and the outer cap, with no contamination of the milk stated.
Plain-English summary
Pasteurized Donor Human Milk, supplied in 4 oz plastic bottles, is being recalled. The action covers 209 bottles.
The stated reason is foreign material: plastic particulate from the outer closure found between the immediate closure, which is a foil seal, and the outer closure, which is a plastic cap. The FDA classified the action as Class III, its least serious classification.
Affected batches are 000230-1, expiring 1/5/2026, and 000235-1, expiring 9/5/2025. Distribution was in Michigan.
Facilities and carers holding affected bottles should follow the instructions issued by the supplier.
The recalled product
- Product
- Pasteurized Donor Human Milk , 4oz plastic bottle
- Manufacturer
- Henry Ford Milk Bank- Jackson
- Category
- Food — Donor human milk
- Affected units
- 209
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 (2)
- Batch 000230-1
- Expiration date 1/5/2026 Batch 000235-1 Expiration date 9/5/2025
Distribution
Distributed in 1 state:
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