FDA Drug recall D-0533-2026
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01
- FDA Drug
- Class III
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class III recall of Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01 by Lannett, 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-0533-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-04-24 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Identifiers
| ndc | 0527-1301-01 |
|---|---|
| ndc | 0527-1301-05 |
| ndc | 0527-1301-10 |
| ndc | 0527-1231-01 |
| ndc | 0527-1231-05 |
| ndc | 0527-1231-10 |
| code_info | Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028. |
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-0533-2026%22
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