The Recall Desk
HighFDA (Food)·H-0386-2025·Announced 2025-08-13

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.

What this means for you

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
Hazard
  • pasteurization
  • thermometer-error
  • infant-product
  • class-ii

Distribution

Distributed in 9 states:

  • MN
  • MO
  • NC
  • NJ
  • OH
  • PA
  • SC
  • VT
  • WV