Primidone Tablets — Class III drug recall D-0585-2026
Ongoing recall by Amneal Pharmaceuticals, LLC, reported 2026-06-17, distributed nationwide. Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to
| Recall number | D-0585-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States |
| Recall initiated | 2026-06-03 |
| Classified | 2026-06-10 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| NDC | 53746-0544, 53746-0544-01, 53746-0544-05, 53746-0544-10, 53746-0545, 53746-0545-01, 53746-0545-05, 53746-0545-10 |
| Lot numbers | AM251676 |
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
Reason for recall
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0585-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.