Class II · Moderate risk
Testo-200
Marketed Without an Approved NDA/ANDA
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Icosapent Ethyl Capsules 1 gram
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Azelastine HCl Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
DOBUTamine Injection
Discoloration; discolored solution from cracked vials
Class II · Moderate risk
Lacosamide Oral Solution
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Metoclopramide Tablets
Presence of foreign tablets/capsules.
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk
Spectrum Advanced Gel Hand Sanitizer
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility