← FDA ENFORCEMENT
D-0585-2026Class III

Amneal Pharmaceuticals, LLC

Recalling firm
Amneal Pharmaceuticals, LLC
Product type
Drug
Status
Ongoing
Report date
2026-06-17
Distribution
Nationwide within the USA.
Firm state
NJ
Product quantity
27,936 100-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Product description

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01

Code / lot info

Lot AM251676, EXP 11/31/2028

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IICareFusion 213, LLC2026-07-22Class IIChiesi USA, Inc.
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.