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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Out of specification for assay
Failed Dissolution Specifications
Subpotent Drug
Out of specification for assay
Cross Contamination with Other Products
Cross Contamination with Other Products
Cross Contamination with Other Products
Cross Contamination with Other Products
Sub-potent Drug; powder discoloration associated with decreased potency
Sub-potent Drug; powder discoloration associated with decreased potency
FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans.
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
CGMP Deviations
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.