Primidone Tablets USP — Class III drug recall D-0533-2026
Ongoing recall by Lannett Company Inc., reported 2026-05-27, distributed nationwide. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
| Recall number | D-0533-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company Inc., Seymour, IN, United States |
| Recall initiated | 2026-04-24 |
| Classified | 2026-05-18 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 44,865 bottles |
| NDC | 00527-1231, 00527-1231-01, 00527-1231-05, 00527-1231-10, 00527-1301, 00527-1301-01, 00527-1301-05, 00527-1301-10 |
| Lot numbers | 25283038A, 25283564A, 25283565A, 25284105A, 25284874A, 25284875A, 25285712A |
| Expiration dates | 2028-01-31, 2028-03-31, 2028-04-30, 2028-08-31 |
Product
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0533-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.