Labetalol Hydrochloride Injection — Class II drug recall D-1424-2014
Terminated recall by Hospira Inc., reported 2014-07-16, distributed nationwide. Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solutio
| Recall number | D-1424-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-05-16 |
| Classified | 2014-07-08 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2017-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 45,448 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00409-0125, 00409-0125-01, 00409-0125-25, 00409-2267, 00409-2267-20, 00409-2267-54 |
| Lot numbers | 36225DD |
| Expiration dates | 2015-12-01 |
Product
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20
Reason for recall
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
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-1424-2014. 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.