Diltiazem HCl Extended Release Capsules — Class III drug recall D-1557-2014
Terminated recall by Mylan Pharmaceuticals Inc., reported 2014-09-03, distributed nationwide. Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtaine
| Recall number | D-1557-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2014-06-19 |
| Classified | 2014-08-22 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 2,658 bottles |
| Reason classes | specification failure |
| NDC | 00378-5220-05 |
| Lot numbers | 07/14, 3040063 |
Product
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Reason for recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
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-1557-2014. 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.