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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.
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
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Lack of Sterility Assurance
Lack of Sterility Assurance
Lack of Sterility Assurance
Lack of Sterility Assurance
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Lack of Sterility Assurance: customer report of leaking bag
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.