Primidone Tablets — Class III drug recall D-0536-2026
Ongoing recall by Amerisource Health Services LLC, reported 2026-05-27, distributed nationwide. Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
| Recall number | D-0536-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2026-05-01 |
| Classified | 2026-05-18 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 63,500 tablets |
| NDC | 68084-0202, 68084-0202-01, 68084-0202-11, 68084-0203, 68084-0203-01, 68084-0203-11 |
| Lot numbers | 1027583 |
| Expiration dates | 2027-09-30 |
Product
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 NDC: 68084-203-11
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-0536-2026. 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.