Acamprosate Calcium — Class II drug recall D-0774-2026
Ongoing recall by Mylan Pharmaceuticals Inc, reported 2026-08-26, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0774-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2026-07-24 |
| Classified | 2026-08-19 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00378-6333, 00378-6333-80 |
| Lot numbers | 3227809 |
| Expiration dates | 2026-10 |
Product
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
Reason for recall
Failed Dissolution Specifications
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-0774-2026. 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.