Pasteurized Donor Human Milk in 4 ounce/120 ml clear plastic bottles. The bottles have a foil seal and are capped with
Summary
The FDA issued a Class II for Pasteurized Donor Human Milk in 4 ounce/120 ml clear plastic bottles. The bottl by The New York Milk Bank, Inc.. Reason: Foreign object.
Details
Source
Food Recall
External ID
H-0308-2026
Action Date
2025-12-24
Status
Terminated
Category
food
Product Description
Pasteurized Donor Human Milk in 4 ounce/120 ml clear plastic bottles. The bottles have a foil seal and are capped with a green lid. Bottle size: 120ml
Lot/Code Info: Batch number: 14559-01, Product type: Term milk, Expiration Date: 5/12/26
Quantity Affected: 66 bottles
Reason for Recall
Foreign object
Distribution
NY
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-11
Company
Valhalla, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 87 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The New York Milk Bank, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The New York Milk Bank, Inc. have FDA actions?
This is the only FDA action we have on record for The New York Milk Bank, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0308-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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