Nicardipine Hydrochloride Injection — Class III drug recall D-0413-2015
Terminated recall by Mylan Institutional LLC, reported 2015-03-25, distributed nationwide. Subpotent Drug and Failed Impurities/Degradation Specifications
| Recall number | D-0413-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2015-01-23 |
| Classified | 2015-03-16 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 78,090 vials |
| Reason classes | potency, specification failure |
| NDC | 67457-0224-10 |
| Lot numbers | 02/15, 04/15, UW301, UW302, UW303, UW304, UW305, UW306 |
Product
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
Reason for recall
Subpotent Drug and Failed Impurities/Degradation Specifications
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-0413-2015. 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.