Class II · Moderate risk Ongoing
Lanthanum Carbonate chewable tablets
Reason Failed stability specifications: Out of specification for hardness test
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Lanthanum Carbonate chewable tablets
Reason Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk Ongoing
Bromocriptine Mesylate Capsules
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class II · Moderate risk Ongoing
clomiPRAMINE Hydrochloride
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk Ongoing
clomiPRAMINE Hydrochloride
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk Ongoing
clomiPRAMINE Hydrochloride
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk Ongoing
Tylenol
Reason Defective Container
Class II · Moderate risk Ongoing
Opdualag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
NIACIN Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Acetaminophen 500mg Caffeine 65mg caplets
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk Ongoing
Tirzepatide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide Pellet
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide Pellet
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide 50MG/10MCG
Reason CGMP Deviations: Potential presence of metal particulate matter