Lannett Company Inc.: Primidone Tablets Usp, 250mg, 100-count Bottle

Recall Summary Lannett Company is recalling Primidone Tablets USP 250mg (100-count bottles) distributed nationwide because the active ingredient was contaminated with trace amounts of Acemetacin, a different drug, during manufacturing. This recall affects prescription bottles distributed across all U.S. states and Washington D.C. The FDA has classified this as a Class III recall.

Recalling firm

Lannett Company Inc.

Product

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Reason

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

Classification

Class III

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-04-24

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/fb5df28c-9b25-4c76-8d7e-e8f3889dac7a