FDA-Drug2026-05-27Class IIICHEMICAL

Lannett Primidone Tablets 250mg recalled for Acemetacin contamination

UNDECLARED INGREDIENTSNationwide distributionDrugs

What this means

Lannett Company's Primidone Tablets 250mg were contaminated during manufacturing with trace amounts of Acemetacin, a different active pharmaceutical ingredient. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

  • Check your Primidone bottle for one of the affected lot numbers listed on FDA.gov
  • Contact your pharmacist or doctor if you have an affected lot
  • Do not stop taking your medication without talking to your doctor first
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
44865 bottles
Manufactured in
1101 C Ave W, Seymour, IN, United States
Products
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2026

More Lannett recalls

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