FDAHealthJune 3, 2026
Amneal Pharmaceuticals, LLC — Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distr
⚠️ Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 3, 2026
Nationwide within the USA.
What's affected?
- 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
- Brand
- PRIMIDONE
- Lot code
- AM251676
Additional details
Lot AM251676, EXP 11/31/2028
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 27,936 100-count bottles.
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