NIFEdipine EXTENDED-RELEASE TABLETS — Class II drug recall D-0652-2021
Terminated recall by The Harvard Drug Group, reported 2021-07-21, distributed in NJ, OH. Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
| Recall number | D-0652-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2021-07-02 |
| Classified | 2021-07-09 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2022-12-28 |
| Distributed | NJ, OH |
| Reason classes | specification failure |
| NDC | 00904-7080, 00904-7080-06, 00904-7080-61, 00904-7081, 00904-7081-06, 00904-7081-61, 00904-7082, 00904-7082-04, 00904-7082-06 |
| Expiration dates | 2022-09 |
Product
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
Reason for recall
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
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-0652-2021. 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.