FDA Drug recall D-0537-2026
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Colu…
- FDA Drug
- Class III
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class III recall of Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Colu… by Amerisource Health Services, citing cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0537-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-05-01 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
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 NDC: 68084-202-11
Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Identifiers
| ndc | 68084-203-11 |
|---|---|
| ndc | 68084-203-01 |
| ndc | 68084-202-11 |
| ndc | 68084-202-01 |
| code_info | Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0537-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.