Drug recall
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by…
FDA recall event 98884 · Class III · Amerisource Health Services LLC
Key facts
| Event ID | 98884 |
|---|---|
| Recall numbers | D-0536-2026, D-0537-2026 |
| Recalling firm | Amerisource Health Services LLC |
| Product type | Drugs |
| Products | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose…, Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. |
| Initiation date | May 1, 2026 |
| Report date | May 27, 2026 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3000209995 |
At a glance
- 1–9 Products in this recall
- 10–99 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: