Labetalol Hydrochloride Injection — Class II drug recall D-0576-2018
Terminated recall by Hospira Inc. A Pfizer Company, reported 2018-03-14, distributed nationwide. Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
| Recall number | D-0576-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc. A Pfizer Company, Mcpherson, KS, United States |
| Recall initiated | 2018-02-20 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2020-04-02 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, packaging |
| NDC | 00409-0125, 00409-0125-01, 00409-0125-25, 00409-2267, 00409-2267-20, 00409-2267-25, 00409-2267-54 |
| Expiration dates | 2019-02-01, 2019-03-01 |
Product
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
Reason for recall
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
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-0576-2018. 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.