Primidone Tablets recall (Amerisource Health Services LLC)
DrugClass IIIOngoing
Summary: Amerisource Health Services LLC is recalling Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What is being recalled
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Why
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot#: 1027583, Exp 09/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0536-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | May 1, 2026 |
| Reported | May 27, 2026 |
| Company | Amerisource Health Services LLC |
| Company location | Columbus, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 63,500 tablets |
More recalls from Amerisource Health Services LLC · all drug recalls · recalls from May 2026