FDA Drug recall D-0535-2026
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camaril…
- FDA Drug
- Class III
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class III recall of Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camaril… by Golden State Medical Supply, 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-0535-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-04-27 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | US |
Product
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Identifiers
| ndc | 51407-637-01 |
|---|---|
| ndc | 51407-637-05 |
| ndc | 51407-638-01 |
| code_info | Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026 |
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-0535-2026%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.