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All product recalls associated with Pfizer Inc..
Total Recalls
148
Past Year
6
Class I (Serious)
22
Most Recent
Aug 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Presence of Particulate Matter; glass particulates
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Superpotent Drug.
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 inside a case of Magnesium Sulfate in Water for Injection.
CGMP Deviations; rejected product was used to manufacture final bulk lot
Lack of assurance of sterility: loss of container integrity.
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 button.
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Microbial Contamination of Non-Sterile Products