Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Azelaic Acid Gel
Reason CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk Ongoing
Phenylephrine HCI
Reason CGMP Deviations
Class I · High risk Ongoing
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Reason Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II · Moderate risk Ongoing
Carbamazepine Extended-Release Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Bupropion Hydrochloride Extended-Release Tablets USP
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
edunn clarity
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Micronized BPO Gel Cleanser 10%
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
mel rx Skin
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Skin MD by Dr Monika Kiripolsky
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Artisan of Skin
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class III · Low risk Ongoing
Espumil
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg
Reason Tablet/Capsules Imprinted with Wrong ID
Class III · Low risk Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg
Reason Tablet/Capsules Imprinted with Wrong ID
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Cyclophosphamide Injection 500 mg/5 mL
Reason cGMP deviations: Temperature excursion during transportation.
Class III · Low risk Ongoing
Everolimus tablets 5mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.