Pfizer Inc.

FDA Regulatory Profile

Summary

Total Recalls
126 (17 Class I)
510(k) Clearances
30
Inspections
52
Compliance Actions
3

Known Names

zydus pharmaceuticals usa, hospira inc a pfizer, hospira inc lake forest, wyeth pharmaceuticals llc a subsidiary of pfizer, king legacy a wholly owned subsidiary of pfizer, wyeth pharmaceutical division of wyeth holdings, pfizer us pharmaceutical group, hospira-inc-a-pfizer, hospira-a-pfizer, hospira-inc-lake-forest

Recent Recalls

NumberClassProductDate
D-0590-2025Class IIVial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc.,August 4, 2025
D-0591-2025Class IIVial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., August 4, 2025
D-0575-2025Class IILevoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: PfizJuly 29, 2025
D-0544-2025Class IIBicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, RxJuly 10, 2025
D-0545-2025Class IIBicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, RxJuly 10, 2025
D-0489-2025Class IIDOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 FliptMay 28, 2025
D-0565-2024Class IILabetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile CaMay 20, 2024
D-0564-2024Class IIBuprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile CartridgeMay 20, 2024
D-0235-2024Class IAtropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use SyrinDecember 21, 2023
D-0233-2024Class I4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe,December 21, 2023
D-0261-2024Class IBleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, DistribuDecember 21, 2023
D-0234-2024Class I8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of December 21, 2023
D-0101-2024Class I1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as October 2, 2023
D-0102-2024Class I2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged asOctober 2, 2023
D-0100-2024Class I4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, October 2, 2023
D-0532-2023Class IIIMEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma IncMarch 8, 2023
D-0097-2023Class IIHeparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,December 29, 2022
D-0184-2023Class IVancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, December 22, 2022
D-0003-2023Class IIAminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, DistributeSeptember 27, 2022
D-1540-2022Class IPROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409August 22, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K181102ThermaCare Quick Therapy TENSSeptember 15, 2018
K991620VISINE FOR CONTACTSSeptember 24, 1999
K892264ORALCHEK SUPER-SOFT BRUSHJune 14, 1989
K892360WATER JEL STERILE GEL-SOAKED BURN DRESSINGJune 5, 1989
K881378PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDEJune 17, 1988
K854726MEDI-WIPES UNITED ANTISEPTIC SKIN PREPFebruary 24, 1986
K850840HOWMEDICA THREADED ACETABULAR COMPONENTJuly 15, 1985
K850443MEC ROD CONNECTORJuly 15, 1985
K850403MEC DISTAL FEMORAL BOLTJuly 15, 1985
K850413MEC HIP BOLTJuly 15, 1985
K851971SERIES 7000/HOLTER RECORDERJune 20, 1985
K852041DEKNATEL THORACIC CATHETERJune 17, 1985
K851024PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVEMay 23, 1985
K850444MEC BUTRESS PLATEApril 19, 1985
K850441MEC INTRAMEDULLARY RODApril 19, 1985
K850442MEC BROAD BONE PLATEApril 19, 1985
K850886COMPRESSION HIP SCREW SYSTEMApril 19, 1985
K850401LETOURNEL ACETABULAR PLATEApril 19, 1985
K844938UNITED SKIN BARRIERSJanuary 18, 1985
K792349SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.March 12, 1980