OhioHealth Mothers Milk Bank Recall Lawsuit | 2026 Latest Updates

OhioHealth Mothers’ Milk Bank voluntarily recalled OH MMB Human Donor Milk. The company started the recall on July 14, 2025. The FDA classified it as Class II. In all, 5,735 bottles went to nine states. The FDA record blames an inaccurate reading on the thermometer of one pasteurization machine. OhioHealth says every recalled batch tested negative for bacterial contamination before it went out. The FDA record states no reported illnesses. The FDA lists the recall as Terminated. Families with this milk in 3 oz or 6 oz bottles can check the batch numbers in the FDA record. They can also talk to the baby’s doctor.

Latest OhioHealth Mothers Milk Bank Recall Updates

September 17, 2025: FDA Lists the Recall as Terminated

The FDA enforcement record lists recall H-0386-2025 as Terminated, with a termination date of September 17, 2025 [1]. This ends the recall of OH MMB Human Donor Milk that OhioHealth Mothers’ Milk Bank began on July 14, 2025. The same record calls the recall voluntary and firm-initiated. It carries no separate public announcement date. The openFDA data behind the record was last updated on September 23, 2026.

August 13, 2025: FDA Enforcement Report Carries the Recall

The FDA enforcement report carried recall H-0386-2025 (event 97261) with a report date of August 13, 2025. The FDA record lists no separate recall hotline. The entry names OhioHealth Mothers’ Milk Bank as the recalling firm, at 4850 E Main St, Suite 140, Columbus, Ohio 43213. It lists OH MMB Human Donor Milk in 3 oz and 6 oz plastic bottles.

August 5, 2025: Newsweek Reports OhioHealth’s Statement

Newsweek reported that the FDA listed the recall as ongoing as of August 5, 2025 [2]. It added that people in the affected states are urged not to use the recalled products. Newsweek updated the report that afternoon with comment that an OhioHealth spokesperson gave by email, saying the milk bank has worked closely with the FDA on the recall process.

August 4, 2025: FDA Classifies the Recall as Class II

The FDA classified the recall as Class II, the second of its three recall classes, under 21 CFR 7.3 [3]. The first class covers a reasonable probability that use will cause serious adverse health consequences or death. Use of a Class II product may cause temporary or medically reversible adverse health consequences, or the chance of serious ones is remote.

July 14, 2025: OhioHealth Starts a Voluntary Recall

OhioHealth Mothers’ Milk Bank voluntarily began recalling OH MMB Human Donor Milk on this date. Newsweek describes the firm as a Columbus-based nonprofit. The FDA record files the recall under product type Food and lists e-mail as the firm’s first notification method. The recall covers 5,735 bottles of the milk, 4,006 of 3 oz and 1,729 of 6 oz.

Which OhioHealth Mothers Milk Bank Products Are Affected?

The FDA record lists two OH MMB Human Donor Milk products at 20.00 Cal/oz, and its code_info field gives every batch number with its expiry date:

• 1.00 g/dl protein, in 3 oz plastic bottles: 4,006 units, with 134 batch numbers and expiry dates from August 12, 2025 to February 1, 2026.
• 0.80 g/dl protein, 6 oz bottles: 1,729 units, 69 batches, expiring September 1, 2025 to February 3, 2026.
• The milk went to Minnesota, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Vermont and West Virginia.

Batch numbers have the form 015637-3. The FDA notes that the exact concentration of protein varies based on the needs of each individual.

Why Was OhioHealth Mothers Milk Bank Recalled?

OH MMB Human Donor Milk was recalled because of an inaccurate temperature reading from a thermometer on one pasteurization machine. The FDA record gives this as the reason for the recall. According to an OhioHealth spokesperson quoted by Newsweek, the milk bank tests every batch for bacterial contamination. All recalled batches tested negative before shipping. The tests followed standards from the Human Milk Banking Association of North America (HMBANA), which says it believes in a world where all infants have access to human milk. The spokesperson also called the recall a proactive step taken out of an abundance of caution for a limited number of batches. Both statements are the company’s own, not FDA findings.

Reported Incidents, Injuries, or Illnesses

The FDA record for this recall lists no illnesses, injuries or deaths and names no pathogen, and Newsweek’s report on the recall describes no illness or injury. A recall report alone does not show that a product caused harm. Newsweek also urged consumers in affected states to consult health providers about possible exposure. According to Newsweek, OhioHealth notified the entities and people who received the recalled product. The FDA record has no remedy field, and refund terms are not stated. The FDA takes consumer reports of problems with the products it regulates, foods included, through its Report a Product Problem page [4].

What Should Consumers Do?

If your baby may have received this milk, take these steps:

1. Check any recently received milk bank products for recall status, as Newsweek reports customers were advised. The batch numbers and expiry dates are in the FDA record.
2. Contact OhioHealth Mothers’ Milk Bank at (614) 566-0630, the number on its own page, or contact your state health department for further instruction.
3. Ask the baby’s healthcare provider about feeding choices. FDA guidance on donor human milk says this decision should be made in consultation with that provider [5].
4. Seek medical help right away for an infant with symptoms of neonatal sepsis, a blood infection in infants. MedlinePlus lists breathing problems, seizures and vomiting among the symptoms [6].
5. Report a problem with the milk to the FDA, or call 1-888-INFO-FDA (1-888-463-6332).

Legal Options

As of September 29, 2026, no lawsuit or class action had been filed over the OhioHealth Mothers’ Milk Bank recall [7, 8]. A recall does not automatically establish liability or eligibility for compensation, and the searches cover only federal court records in that archive.

Frequently Asked Questions

Where Can I Find the Batch Numbers for the Recalled OhioHealth Milk?

You can find the batch numbers for the recalled OhioHealth milk in the FDA enforcement record for this recall. It lists 203 batch entries in all, and batch 015889-2 appears in both the 3 oz and the 6 oz lists.

How Much Donor Milk Did OhioHealth Recall?

OhioHealth recalled about 175 gallons of donor milk, or 22,392 fluid ounces in all. That total comes from multiplying the FDA record’s unit counts by the 3 oz and 6 oz bottle sizes.

What Is Donor Human Milk Used For?

Donor human milk is used when mothers are not producing enough milk or when parents have adopted, Newsweek reports. It is also often given to premature or low birth weight infants.

Is Donor Milk from a Milk Bank Safe for Babies?

For donor milk from a milk bank, the FDA recommends a source that has screened its milk donors and taken other precautions for safety, after consulting a healthcare provider. The FDA says human milk banks have established standards to screen donors and safely handle the milk.

What Are the Symptoms of Neonatal Sepsis in a Newborn?

MedlinePlus lists body temperature changes, low blood sugar, reduced sucking, a swollen belly area and jaundice among the symptoms of neonatal sepsis in a newborn. These are general symptoms of a blood infection in infants under 90 days old, not reported effects of this recall.

Does the FDA Regulate Donor Milk Banks?

Yes, the FDA regulates donor human milk banks and their milk under its regulatory authority for foods. It also inspects donor human milk banks against its current good manufacturing practice and preventive controls rule for human food. The OhioHealth recall appears in FDA enforcement data.

References

1. https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0386-2025%22
2. https://www.newsweek.com/baby-milk-recall-nine-states-fda-risk-warning-2109036
3. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-A/section-7.3
4. https://www.fda.gov/safety/report-problem-fda
5. https://www.fda.gov/science-research/pediatrics/use-donor-human-milk
6. https://medlineplus.gov/ency/article/007303.htm
7. https://www.courtlistener.com/api/rest/v4/search/?q=%22Mothers%27+Milk+Bank%22&type=r
8. https://www.courtlistener.com/api/rest/v4/search/?q=OhioHealth+%22milk%22&type=r&filed_after=2025-07-01