FDA Drug recall D-0652-2021
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61
- FDA Drug
- Class II
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61 by The Harvard Drug Group, citing failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0652-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-02 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | NJ, OH |
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
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Identifiers
| ndc | 0904-7080-06 |
|---|---|
| ndc | 0904-7080-61 |
| ndc | 0904-7081-06 |
| ndc | 0904-7081-61 |
| ndc | 0904-7082-04 |
| ndc | 0904-7082-06 |
| code_info | Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0652-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.