FDA-Drug2026-05-27Class IIICHEMICAL
Amerisource Health Services Primidone Tablets recalled for trace Acemetacin contamination
What this means
Amerisource Health Services has recalled certain batches of Primidone Tablets, USP, 50 mg due to cross-contamination during manufacturing. The tablets contain trace amounts of Acemetacin, a different active pharmaceutical ingredient, which should not be present in this medication.
- Check your Primidone tablet carton for lot number 1028739 (expires 12/31/2027) or lot 1025622 (expires 06/30/2027).
- If you have one of the affected lots, contact your pharmacy or healthcare provider before taking any more tablets.
- Do not discard medication without guidance — ask your pharmacist or doctor how to safely dispose of it.
The agency's original wording
Hazard
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
225,000 tablets
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0537-2026Want us to check the next one for you?
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