Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
FDA Drug Recalls
721 recalls, newest first
Class II · Moderate risk
GHK-Cu (Copper Peptide)
Lack of Assurance of Sterility
Class II · Moderate risk
GAC for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Biotin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B6 (Pyridoxine HCl) for Injections
Lack of Assurance of Sterility
Class II · Moderate risk
B5 Dexpanthenol for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Blend for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alpha Lipoic Acid for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sucralfate Tablets
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
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Doxepin Hydrochloride Capsules
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk
BZK Antiseptic Towelette
Lack of Assurance of Sterility.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class II · Moderate risk
Quick Touch Alcohol Prep Pads
cGMP Deviations
Class II · Moderate risk
Belsomra (suvorexant)
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.
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: low dissolution results