FDA DrugsClass III
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by:...
Published: June 17, 2026Recall ID: D-0585-2026Category: drugsCountry: US
Reason for Recall / Hazard
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Nui › 1 | N0000175753 |
| Openfda › Nui › 2 | N0000008486 |
| Openfda › Unii | 13AFD7670Q |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 96304 |
| Openfda › Rxcui › 2 | 198150 |
| Openfda › Spl id | 574c0bff-04c5-41f0-8d10-315a824d8efd |
| Openfda › Brand name | PRIMIDONE |
| Openfda › Spl set id | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce |
| Openfda › Package ndc › 1 | 53746-544-01 |
| Openfda › Package ndc › 2 | 53746-544-10 |
| Openfda › Package ndc › 3 | 53746-544-05 |
| Openfda › Package ndc › 4 | 53746-545-01 |
| Openfda › Package ndc › 5 | 53746-545-10 |
| Openfda › Package ndc › 6 | 53746-545-05 |
| Openfda › Product ndc › 1 | 53746-544 |
| Openfda › Product ndc › 2 | 53746-545 |
| Openfda › Generic name | PRIMIDONE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| Openfda › Substance name | PRIMIDONE |
| Openfda › Pharm class epc | Anti-epileptic Agent [EPC] |
| Openfda › Manufacturer name | Amneal Pharmaceuticals of New York LLC |
| Openfda › Application number | ANDA040866 |
| Openfda › Is original packager | true |
| Event id | 99146 |
| Address 1 | 400 Crossing Blvd Fl 3 |
| Address 2 | N/A |
| Code info | Lot AM251676, EXP 11/31/2028 |
| Postal code | 08807-2863 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 27,936 100-count bottles |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260603 |
| Initial firm notification | Letter |
| Center classification date | 20260610 |
Overview
- Recalling FirmAmneal Pharmaceuticals, LLC
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide within the USA.