Class II · Moderate risk Ongoing
Glycine for Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Glutathione Preserved for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Glutathione Magnesium for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
GHK-Cu
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
GAC for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Calcium Chloride for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Biotin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B-Complex for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Bacteriostatic Water for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B6 (Pyridoxine HCl) for Injections
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B5 Dexpanthenol for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B12 Methylcobalamin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B12 Hydroxocobalamin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amino Blend for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Alpha Lipoic Acid for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sucralfate Tablets
Reason CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk Ongoing
Levoxyl
Reason Subpotent drug
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
Doxepin Hydrochloride Capsules
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
BZK Antiseptic Towelette
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class II · Moderate risk Ongoing
Quick Touch Alcohol Prep Pads
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Belsomra
Reason Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.