Primidone Tablets recall: Contamination
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
Why was Primidone Tablets recalled?
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot AM251676, EXP 11/31/2028
- Product
- 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
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Quantity
- 27,936 100-count bottles
- Distribution
- Nationwide within the USA.
- Recall date
- June 17, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)