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.
Other recalls by Heritage Pharmaceuticals
- CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Br…
FDA Drug · Class II · 2026-08-19 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman,…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
All Heritage Pharmaceuticals recalls
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.