Felodipine Extended Release Tablets — Class III drug recall D-0108-2021
Terminated recall by Heritage Pharmaceuticals Inc, reported 2020-12-02, distributed nationwide. Failed impurities/ degradation specifications: Out of specification impurity results were observed during rout
| Recall number | D-0108-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals Inc, East Brunswick, NJ, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-11-25 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2022-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 7,176 bottles |
| Reason classes | specification failure |
| NDC | 23155-0048, 23155-0048-01, 23155-0049, 23155-0049-01, 23155-0050, 23155-0050-01 |
| Lot numbers | 18029979 |
| Expiration dates | 2021-01 |
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 for recall
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
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-0108-2021. 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.