Labetalol Hydrochloride Injection — Class II drug recall D-0565-2024
Ongoing recall by Pfizer Inc., reported 2024-07-03, distributed nationwide. Lack of Assurance of Sterility-The potential for incomplete crimp seals.
| Recall number | D-0565-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2024-05-20 |
| Classified | 2024-06-22 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Quantity | 220,400 cartridges |
| Reason classes | sterility |
| NDC | 00409-2339, 00409-2339-24, 00409-2339-34 |
| Lot numbers | 2025/05, 2025/09, HJ7566, HN8747, HN8749 |
Product
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
Reason for recall
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
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-0565-2024. 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.