Quick Facts at a Glance
- Recall Date
- June 3, 2026
- Hazard Level
- HIGH
- Brands
- PRIMIDONE, Amneal Pharmaceuticals of New York LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- PRIMIDONE, Amneal Pharmaceuticals of New York LLC
- Model numbers
- Lot AM251676, EXP 11/31/2028
- UPC codes
- 53746-544, 53746-545, 53746-544-01, 53746-544-10, 53746-544-05, 53746-545-01, 53746-545-10, 53746-545-05
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 3, 2026
Reported by FDA DRUG
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Full 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. Generic: PRIMIDONE; Brand: PRIMIDONE. Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.. Classification: Class III. Quantity: 27,936 100-count bottles. Distribution: Nationwide within the USA.
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Safety Guide
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