Information
Amneal Pharmaceuticals Recalls Primidone Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0585-2026Drug / Pharmaceutical
Amneal Pharmaceuticals Recalls Primidone Tablets
Amneal Pharmaceuticals, LLC · Class III — Regulatory
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
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.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide within the USA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A regulatory compliance recall has been issued for a pharmaceutical product from Amneal Pharmaceuticals, LLC. The FDA classified this as Class III on June 3, 2026 affecting 27,936 100-count bottles. Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. It was distributed nationwide. While this classification indicates a low probability of adverse health effects, consumers should be aware of the recall and follow any instructions from the manufacturer.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.