Class II · Moderate risk
Finasteride
cGMP deviations
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP deviations
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class III · Low risk
Dofetilide Capsules
Failed Content Uniformity Specifications
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up
Class III · Low risk
MEKTOVI (binimetinib)
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class II · Moderate risk
Calcitonin Salmon Nasal Spray
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Heparin Sodium
Subpotent Drug: low Anti-Factor IIa potency.
Class II · Moderate risk
Brimonidine Tartrate Ophthalmic Solution 0.15%
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class II · Moderate risk
Heparin Sodium Injection
Labeling: Not elsewhere classified
Class I · High risk
Delsam Pharma's Artificial Eye Ointment
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Class III · Low risk
Colchicine Tablets
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class II · Moderate risk
Class II · Moderate risk
Activator Concentrate
CGMP DEVIATIONS
Class II · Moderate risk
Nose Better Gel
CGMP DEVIATIONS
Class II · Moderate risk
Soltice Quick-RUB
CGMP DEVIATIONS