Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
FDA Drug Recalls
18,003 recalls, newest first
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
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Vencedor medicated balm
CGMP DEVIATIONS