DrugAug 12, 2020
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials recall — FDA D-1446-2020
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class IIFDA: TerminatedPfizer Inc.
Recall history in this database
Classification mix: Class II: 48, Class III: 29, Class I: 15.
DrugJul 1, 2020
Pfizer Duavee recall — FDA D-1342-2020
Failed Dissolution Specifications
Class IIIFDA: TerminatedPfizer Inc.
DrugJun 17, 2020
Unasyn recall — FDA D-1306-2020
Presence of Particulate Matter: particulate matter identified after reconstitution.
Class IIFDA: TerminatedPfizer Inc.
DrugMar 11, 2020
Elelyso (taliglucerase alfa) for injection, 200 units/vials recall — FDA D-0995-2020
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic…
Class IIFDA: TerminatedPfizer Inc.
DrugFeb 19, 2020
Pfizer Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial recall — FDA D-0835-2020
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Class IIFDA: TerminatedPfizer Inc.
DrugFeb 19, 2020
Caduet recall — FDA D-0841-2020
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture…
Class IIFDA: TerminatedPfizer Inc.
DrugFeb 19, 2020
Caduet recall — FDA D-0842-2020
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture…
Class IIFDA: TerminatedPfizer Inc.
DrugOct 16, 2019
LMD IN DEXTROSE 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 recall — FDA D-0136-2020
Lack of Assurance of Sterility: Bag has the potential to leak.
Class IIFDA: TerminatedPfizer Inc.
DrugOct 2, 2019
Zarontin recall — FDA D-0002-2020
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class IIIFDA: TerminatedPfizer Inc.
DrugOct 2, 2019
Pfizer ethosuximide capsules, USP, 250 mg, 100-count bottle recall — FDA D-0001-2020
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class IIIFDA: TerminatedPfizer Inc.
DrugSep 18, 2019
Bacteriostatic Water for Injection, USP, 30 mL vials recall — FDA D-1852-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedPfizer Inc.
DrugSep 4, 2019
Pfizer RELPAX (eletriptan HBr) tablets, 40 mg recall — FDA D-1845-2019
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Class IIFDA: TerminatedPfizer Inc.
DrugJul 24, 2019
Pfizer Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 recall — FDA D-1487-2019
Lack of Assurance of Sterility: Bags have the potential to leak.
Class IIFDA: TerminatedPfizer Inc.
DrugJul 24, 2019
Pfizer Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 recall — FDA D-1486-2019
Lack of Assurance of Sterility: Bags have the potential to leak.
Class IIFDA: TerminatedPfizer Inc.
DrugMay 22, 2019
Pfizer Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister recall — FDA D-1278-2019
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to…
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial recall — FDA D-1069-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL recall — FDA D-1073-2019
Presence of Particulate Matter; glass particulates
Class IFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials recall — FDA D-1071-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial recall — FDA D-1072-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Pfizer Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials recall — FDA D-1070-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial recall — FDA D-1068-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 10, 2019
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial recall — FDA D-1067-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class IIIFDA: TerminatedPfizer Inc.
Medical DeviceDec 12, 2018
Pfizer Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage recall — FDA Z-0555-2019
The firm received complaints of the wrap coming apart and leaking granular material
Class IIFDA: TerminatedPfizer Inc.
Medical DeviceDec 12, 2018
Pfizer Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product recall — FDA Z-0554-2019
The firm received complaints of the wrap coming apart and leaking granular material
Class IIFDA: TerminatedPfizer Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Pfizer Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.