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All product recalls associated with Pfizer Inc..
Total Recalls
120
Past Year
5
Class I (Serious)
16
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.
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
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
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Presence of Particulate Matter: glass particulate found in vial
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Failed Dissolution Specifications
Failed Dissolution Specifications