Diltiazem HCl Extended-release Capsules — Class III drug recall D-1112-2018
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2018-08-29, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufa
| Recall number | D-1112-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2018-08-14 |
| Classified | 2018-08-22 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 408 cartons |
| Reason classes | specification failure |
| NDC | 51079-0947-08 |
| Lot numbers | 3096049 |
Product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Reason for recall
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
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-1112-2018. 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.