FDA Drug recall D-0108-2021
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class III recall of Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc by Heritage Pharmaceuticals, citing failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0108-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-10-23 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
Product
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
Reason
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Identifiers
| ndc | 23155-048-01 |
|---|---|
| ndc | 23155-049-01 |
| ndc | 23155-050-01 |
| code_info | Lot #: 18029979, Exp 1/2021 |
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-0108-2021%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.