Drug recall
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt…
FDA recall event 99146 · Class III · Amneal Pharmaceuticals, LLC
Key facts
| Event ID | 99146 |
|---|---|
| Recall numbers | D-0585-2026 |
| Recalling firm | Amneal Pharmaceuticals, LLC |
| Product type | Drugs |
| 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… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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. |
| Initiation date | Jun 3, 2026 |
| Report date | Jun 17, 2026 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3012625281 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: