Pfizer Inc.
Pfizer Inc. appears in FDA public data with 126 recalls — including 17 Class I (most serious) —, 30 510(k) clearances, 46 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0591-2025, Class II) was initiated on August 4, 2025. Its most recent 510(k) clearance was granted on September 15, 2018.
Summary
- Total Recalls
- 126 (17 Class I)
- 510(k) Clearances
- 30
- Inspections
- 46
- 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, pfizer us pharmaceutical group, pfizer, hospira-inc-a-pfizer, hospira-a-pfizer, hospira-inc-lake-forest
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0591-2025 | Class II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., | August 4, 2025 |
| D-0590-2025 | Class II | Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., | August 4, 2025 |
| D-0575-2025 | Class II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfiz | July 29, 2025 |
| D-0545-2025 | Class II | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx | July 10, 2025 |
| D-0544-2025 | Class II | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx | July 10, 2025 |
| D-0489-2025 | Class II | DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Flipt | May 28, 2025 |
| D-0564-2024 | Class II | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge | May 20, 2024 |
| D-0565-2024 | Class II | Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Ca | May 20, 2024 |
| D-0235-2024 | Class I | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syrin | December 21, 2023 |
| D-0234-2024 | Class I | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of | December 21, 2023 |
| D-0233-2024 | Class I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, | December 21, 2023 |
| D-0261-2024 | Class I | Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distribu | December 21, 2023 |
| D-0102-2024 | Class I | 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as | October 2, 2023 |
| D-0101-2024 | Class I | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as | October 2, 2023 |
| D-0100-2024 | Class I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, | October 2, 2023 |
| D-0532-2023 | Class III | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc | March 8, 2023 |
| D-0097-2023 | Class II | Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1, | December 29, 2022 |
| D-0184-2023 | Class I | Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, | December 22, 2022 |
| D-0003-2023 | Class II | Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distribute | September 27, 2022 |
| D-1540-2022 | Class I | PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409 | August 22, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K181102 | ThermaCare Quick Therapy TENS | September 15, 2018 |
| K991620 | VISINE FOR CONTACTS | September 24, 1999 |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | June 14, 1989 |
| K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | June 5, 1989 |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | June 17, 1988 |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | February 24, 1986 |
| K850443 | MEC ROD CONNECTOR | July 15, 1985 |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | July 15, 1985 |
| K850403 | MEC DISTAL FEMORAL BOLT | July 15, 1985 |
| K850413 | MEC HIP BOLT | July 15, 1985 |
| K851971 | SERIES 7000/HOLTER RECORDER | June 20, 1985 |
| K852041 | DEKNATEL THORACIC CATHETER | June 17, 1985 |
| K851024 | PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE | May 23, 1985 |
| K850401 | LETOURNEL ACETABULAR PLATE | April 19, 1985 |
| K850441 | MEC INTRAMEDULLARY ROD | April 19, 1985 |
| K850886 | COMPRESSION HIP SCREW SYSTEM | April 19, 1985 |
| K850442 | MEC BROAD BONE PLATE | April 19, 1985 |
| K850444 | MEC BUTRESS PLATE | April 19, 1985 |
| K844938 | UNITED SKIN BARRIERS | January 18, 1985 |
| K792349 | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. | March 12, 1980 |