Diltiazem HCl Extended-release Capsules — Class III drug recall D-0151-2017
Terminated recall by Mylan Pharmaceuticals Inc., reported 2016-11-30, distributed nationwide. Failed Impurities/Degradation Specifications: OOS results for known compound.
| Recall number | D-0151-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2016-11-03 |
| Classified | 2016-11-23 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 51,983 extended |
| Reason classes | specification failure |
| NDC | 00378-5220-01, 00378-5220-05 |
| Lot numbers | 03/17, 0378-5220-01, 0378-5220-05, 05/17, 08/17, 3065133, 3066564, 3069645 |
Product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Reason for recall
Failed Impurities/Degradation Specifications: OOS results for known compound.
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-0151-2017. 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.