Class II · Moderate risk
Haloperidol decanoate Injection 50mg/mL
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
FDA Drug Recalls
354 recalls, newest first
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets
Class III · Low risk
Xelpros (latanoprost ophthalmic emulsion)
Failed Release Testing: Out of specification for particulate matter test.
Class I · High risk
Tirzepatide 10 mg/0.5 mL Sterile Solution
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class II · Moderate risk
Amphotericin B Liposome for Injection
Out of specification for assay
Class II · Moderate risk
Ful-Glo
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
Ful-Glo
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
GloStrips
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
GloStrips
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
Aloe Gator
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
Class II · Moderate risk
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications
Class III · Low risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Out of specification for assay
Class II · Moderate risk
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products