Pasteurized donor human milk may contain plastic particles
Standard and Pediatric Pasteurized Donor Human Milk is being recalled because the product is potentially contaminated with foreign material, specifically plastic particles.
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: Plastic particles in a product fed to infants are a physical hazard capable of causing injury, a risk of harm with no injuries reported in the source.
Plain-English summary
Standard Pasteurized Donor Human Milk in 100 mL bottles (item 001165) and Pediatric Pasteurized Donor Human Milk in 200 mL bottles (item 001198) are being recalled. The action covers 60 litres, or 441 bottles.
The stated reason is that the product is potentially contaminated with foreign material, specifically plastic particles. The FDA classified the action as Class II.
Affected product carries expiration dates of 8/4/2026 for item 001165 and 10/31/2026 for item 001198, with lot codes listed in the recall notice. The product is distributed to medical facilities and direct to consumers through medical facilities.
Facilities and families holding affected lots should stop using the product and follow the instructions issued by the milk bank. Anyone whose infant has been fed the product and appears unwell should contact a healthcare provider.
The recalled product
- Product
- 001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC
- Manufacturer
- University of California Health Milk Bank
- Category
- Food — Donor human milk
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 (12)
- Expiration dates: 001165: 8/4/2026 001198: 10/31/2026 Lot Codes: 001165-1
- 001165-2
- 001165-3
- 001165-4
- 001165-5
- 001165-6
- 001165-7
- 001165-8 001198-
- 001198-2
- 00198-3
- 001198-4
- 001198-5
Distribution
Distributed in 1 state:
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