Labetalol Hydrochloride Injection (Pfizer) – Crimp Seal Issue (2024)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Lot#: HJ7566, Exp 2025/05 Lot#: HN8747, Exp 2025/09 Lot#: HN8749, Exp 2025/09
Products Sold
Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
Pfizer Inc. is recalling Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Ca due to Lack of Assurance of Sterility-The potential for incomplete crimp seals.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026