Human donor milk recalled over an inaccurate pasteurization machine thermometer reading
OH MMB Human Donor Milk is being recalled because of an inaccurate temperature reading from a thermometer on one pasteurization machine. 5,735 units in total are affected.
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: Risk-of-harm product: a faulty thermometer leaves pasteurization of donor milk for infants unverified, with no illness reported in the source.
Plain-English summary
OH MMB Human Donor Milk, 20.00 Cal/oz, is being recalled in 3 oz plastic bottles at 1.00 g/dl protein (4,006 units) and 6 oz plastic bottles at 0.80 g/dl protein (1,729 units), a total of 5,735 units. The source notes the exact protein concentration varies based on the needs of each individual.
The stated reason is an inaccurate temperature reading from a thermometer on one pasteurization machine. The FDA classified the action as Class II. The source does not report any illness.
Affected batches and expiry dates are listed in the recall notice, including 015637-3 expiring 11/27/2025 and 015639-4 expiring 10/2/2025. Distribution was to Minnesota, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Vermont and West Virginia.
Facilities and carers holding affected bottles should follow the instructions issued by the milk bank.
The recalled product
- Product
- 1) OH MMB Human Donor Milk, 20.00 Cal/oz, 1.00 g/dl Protein, packaged in 3 oz plastic bottles 2) OH MMB Human Donor Milk, 20.00 Cal/oz, 0.80 g/dl Protein, packaged in 6 oz plastic bottles Note: The exact concentration of protein varies based on the needs of each individual.
- Manufacturer
- OHIO HEALTH MOTHER MILK BANK
- Category
- Food — Donor human milk
Distribution
Related recalls
Other food recalls
- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighSaratoga Potato Chips Recalls J. HIGGS Loaded Bacon & Cheddar Chips
FDA (Food) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
- ModerateHolsum Spinach Flour Tortillas Recalled for Undeclared Food Dyes
FDA (Food) · 2026-10-21
- ModeratePur Aqua Sparkling Frost Cherry Limeade Recalled for Undeclared Aspartame
FDA (Food) · 2026-10-21
Similar recalls
- ModeratePasteurized donor human milk bottles show dark spot contamination
FDA (Food) · 2026-06-17
- HighPasteurized donor human milk may contain plastic particles
FDA (Food) · 2026-06-10
- ModerateDonor human milk recalled over a potential physical contaminant in one batch
FDA (Food) · 2025-10-01
- HighMinnesota Milk Bank Donor Human Milk Recalled for Undetermined Foreign Material
FDA (Food) · 2025-01-08
- ModerateMother's Milk Bank of North Texas Pasteurized Donor Human Milk Recalled for Foreign Object
FDA (Food) · 2021-12-22
- ModerateMinnesota Milk Bank Recalls Pasteurized Donor Human Milk
FDA (Food) · 2021-03-24