FDA Drug recall D-1557-2014
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
- FDA Drug
- Class III
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class III recall of Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 by Mylan Pharmaceuticals, citing failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1557-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-06-19 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Identifiers
| code_info | Lot 3040063 Exp. 07/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1557-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.