Class II · Moderate risk Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE…
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
traMADol Hydrochloride Tablets
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk Ongoing
MethylPREDNISolone Acetate Injectable Suspension
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk Ongoing
Haloperidol decanoate Injection 50mg/mL
Reason Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets
Reason Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk Ongoing
Clorazepate Dipotassium Tablets
Reason Discoloration: Dotted and yellow spots on tablets
Class III · Low risk Ongoing
Xelpros
Reason Failed Release Testing: Out of specification for particulate matter test.
Class I · High risk Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution
Reason Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class II · Moderate risk Ongoing
Amphotericin B Liposome for Injection
Reason Out of specification for assay
Class II · Moderate risk Ongoing
Ful-Glo
Reason 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.
Class II · Moderate risk Ongoing
Ful-Glo
Reason 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.
Class II · Moderate risk Ongoing
GloStrips
Reason 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.
Class II · Moderate risk Ongoing
GloStrips
Reason 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.
Class II · Moderate risk Ongoing
Aloe Gator
Reason Out of Specification for active ingredient
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Aloe Gator
Reason Out of Specification for active ingredient
Class II · Moderate risk Ongoing
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with…
Reason Out of Specification for active ingredient