FDA Drug recall D-1186-2018
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class III recall of Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc by Mylan Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1186-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-07 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Reason
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Identifiers
| code_info | Batch code # 3093163, expiration date 04/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1186-2018%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.