Diltiazem HCl Extended-Release Capsules — Class III drug recall D-0506-2019
Terminated recall by Mylan Pharmaceuticals Inc., reported 2019-02-27, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stabil
| Recall number | D-0506-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2019-02-13 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2019-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 8,159 bottles |
| Reason classes | specification failure |
| NDC | 00378-5280-01, 00378-5280-05 |
| Lot numbers | 3090167 |
| Expiration dates | 2019-10-20 |
Product
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results 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-0506-2019. 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.