FDA Drug Recalls

Recalls / Active ingredient / Labetalol Hydrochloride

Labetalol Hydrochloride

4 FDA drug recalls involving the active ingredient “Labetalol Hydrochloride.

DateClassProductFirm
2024-05-20Class IILabetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge UnPfizer Inc.
2022-04-13Class IILabetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01Mckesson Medical-Surgical Inc. Corporate Office
2018-02-20Class IILabetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira Inc. A Pfizer Company
2014-05-16Class IILabetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass Hospira Inc.