Reported Jun 17, 2026 · Ongoing
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral…
Amneal Pharmaceuticals, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863
Is this the product you have?
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA
- Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- NDC53746-544-01
- Lot codes and dates
Lot AM251676EXP 11/31/2028
- Amount recalled
- 27,936 100-count bottles
Where it was sold
- Nationwide
Why it was recalled
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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