Medical DeviceDec 12, 2018
Pfizer Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS recall — FDA Z-0556-2019
The firm received complaints of the wrap coming apart and leaking granular material
Class IIFDA: TerminatedPfizer Inc.
Recall history in this database
Classification mix: Class II: 48, Class III: 29, Class I: 15.
DrugOct 31, 2018
Pfizer Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile recall — FDA D-0095-2019
Lack of assurance of sterility: loss of container integrity.
Class IIFDA: TerminatedPfizer Inc.
DrugOct 17, 2018
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL recall — FDA D-0015-2019
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found…
Class IIFDA: TerminatedPfizer Inc.
DrugOct 10, 2018
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial recall — FDA D-0005-2019
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.
DrugSep 19, 2018
Pfizer Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial recall — FDA D-1184-2018
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Class IIIFDA: TerminatedPfizer Inc.
DrugMar 21, 2018
HYDROMORPHONE HYDROCHLORIDE Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recall — FDA D-0597-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class IFDA: TerminatedPfizer Inc.
DrugMar 21, 2018
HYDROMORPHONE HYDROCHLORIDE Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recall — FDA D-0596-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class IFDA: TerminatedPfizer Inc.
DrugJan 10, 2018
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count recall — FDA D-0150-2018
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class IFDA: TerminatedPfizer Inc.
DrugOct 4, 2017
Pfizer Sterile Water for Injection, USP Single Dose 100 mL vials recall — FDA D-1177-2017
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class IIFDA: TerminatedPfizer Inc.
DrugSep 27, 2017
Pfizer Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL recall — FDA D-1164-2017
Failed Dissolution Specifications
Class IIIFDA: TerminatedPfizer Inc.
DrugSep 27, 2017
Pfizer Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 recall — FDA D-1163-2017
Failed Dissolution Specifications
Class IIIFDA: TerminatedPfizer Inc.
DrugSep 27, 2017
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial recall — FDA D-1167-2017
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class IIFDA: TerminatedPfizer Inc.
DrugSep 27, 2017
Levophed recall — FDA D-1168-2017
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class IIFDA: TerminatedPfizer Inc.
DrugMar 29, 2017
Pfizer Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 recall — FDA D-0608-2017
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class IIIFDA: TerminatedPfizer Inc.
DrugMar 29, 2017
Pfizer Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 recall — FDA D-0607-2017
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class IIIFDA: TerminatedPfizer Inc.
DrugMar 29, 2017
Pfizer Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 recall — FDA D-0609-2017
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class IIIFDA: TerminatedPfizer Inc.
DrugMar 22, 2017
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per recall — FDA D-0516-2017
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class IIIFDA: TerminatedPfizer Inc.
DrugJan 18, 2017
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution recall — FDA D-0424-2017
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class IIIFDA: TerminatedPfizer Inc.
DrugOct 5, 2016
PREMARIN recall — FDA D-1528-2016
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Class IIIFDA: TerminatedPfizer Inc.
DrugFeb 10, 2016
Lyrica (pregabalin) capsules, 75 mg, 90-count bottle recall — FDA D-0649-2016
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class IIFDA: TerminatedPfizer Inc.
DrugFeb 10, 2016
Lyrica (pregabalin) capsules, 50 mg, 90-count bottle recall — FDA D-0648-2016
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class IIFDA: TerminatedPfizer Inc.
DrugDec 17, 2014
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count recall — FDA D-0292-2015
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Class IIFDA: TerminatedPfizer Inc.
DrugNov 12, 2014
TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 recall — FDA D-0235-2015
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected…
Class IIIFDA: TerminatedPfizer Inc.
DrugAug 20, 2014
Depo-Medrol recall — FDA D-1537-2014
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Class IIIFDA: 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.