Felodipine Extended-Release Tablets — Class III drug recall D-1421-2015
Terminated recall by Mutual Pharmaceutical Company, Inc., reported 2015-09-16, distributed nationwide. Chemical Contamination; benzophenone leached from the product label varnish
| Recall number | D-1421-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mutual Pharmaceutical Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2015-07-16 |
| Classified | 2015-09-09 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2016-10-13 |
| Distributed | Nationwide (US) |
| Quantity | 97,859 bottles |
| Reason classes | chemical contamination, labeling |
| NDC | 53489-0369-01 |
| Lot numbers | 10/15, 4/16, 5/16, 6662801, 6662901, 6689601, 6689701, 6708401, 8/16 |
Product
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Reason for recall
Chemical Contamination; benzophenone leached from the product label varnish
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-1421-2015. 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.