FDA-Drug2026-05-27Class IIICHEMICAL
Lannett Primidone Tablets 250mg recalled for Acemetacin contamination
UNDECLARED INGREDIENTSNationwide distribution
Lannett Primidone tablets recalled for API contamination
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
Hazard
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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-0533-2026Don't want to check this manually?
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