FDA Drugs recall ·
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only… recall
- Recall number
- D-0585-2026
- Date
- (initiated June 3, 2026)
- Company / brand
- Amneal Pharmaceuticals, LLC
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 27,936 100-count bottles
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot AM251676, EXP 11/31/2028
Distribution
Nationwide within the USA.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0585-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.