Entacapone Tablets — Class II drug recall D-0806-2021
Terminated recall by The Harvard Drug Group, reported 2021-09-29, distributed in CO, FL, MO, OH. Failed Dissolution Specifications
| Recall number | D-0806-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2021-07-29 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-02-19 |
| Distributed | CO, FL, MO, OH |
| Quantity | 1,632 cartons |
| Reason classes | specification failure |
| NDC | 00904-6822, 00904-6822-04, 00904-6822-07 |
| Lot numbers | N00187, N00245, N00273, N00355 |
Product
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
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-0806-2021. 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.