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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.
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
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.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Superpotent
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.
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Labeling: Label Mix-Up
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Failed Dissolution Specification
Subpotent Drug
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
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 by this issue.
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
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.