United StatesPrimidone Tablets USP, 250 mg, 100-count bottle (Rx only), distributed by Lannett Company, Philadelphia, PA, NDC 0527-1231-01, lots 25283038A (exp 1/31/2028), 25283564A and 25283565A (exp 3/31/2028), 25285712A (exp 8/31/2028), 25284105A (exp 4/30/2028), and 25284874A and 25284875A (exp 8/31/2028) are affected. The product was recalled nationwide because the active pharmaceutical ingredient was contaminated with trace amounts of Acemetacin API; the recall is ongoing.
What's being recalled
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Recalling firm: Lannett Company Inc., Seymour, IN, United States.
How to identify it
Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
The hazard
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)