FDA-Drug2026-05-27Class IIICHEMICAL

Amerisource Primidone 250 mg tablets recalled for cross-contamination with Acemetacin

UNDECLARED INGREDIENTSNationwide distribution

Amerisource Primidone tablets recalled for cross-contamination

Primidone tablets distributed by American Health Packaging were found to contain trace amounts of Acemetacin, a different active pharmaceutical ingredient, due to cross-contamination during manufacturing. The affected lot (1027583, expiring 09/30/2027) contains approximately 63,500 tablets distributed nationwide. No injuries have been reported.

  • Check your Primidone bottles for lot number 1027583 and expiration date 09/30/2027
  • Contact your pharmacy or prescriber if you have this lot
  • Do not use affected tablets without speaking to your healthcare provider first
Hazard

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Sold states
USA Nationwide
Affected count
63,500 tablets
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0536-2026

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