Class I · High risk Ongoing
Weiner Boner Honey
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
Spanish Fly 22K capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class II · Moderate risk Ongoing
Infumorph
Reason The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class I · High risk Ongoing
Treprostinil Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Ongoing
Febuxostat Tablets 80mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Ongoing
Febuxostat Tablets 40mg
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Ongoing
FentaNYL citrate
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk Ongoing
Phenylephrine HCl
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk Ongoing
hyalogic For Dry Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Red Eye Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Pink Eye Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Aging Eye Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Floaters Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Eye strain Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Dryness Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Eye Twitching Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Blur Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes Allergy Eyes Relief
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nicardipine Hydrochloride Injection
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk Ongoing
Nicardipine Hydrochloride Injection
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk Ongoing
Methylprednisolone acetate Injectable Suspension
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Clindamycin Phosphate Topical Solution USP
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk Ongoing
Clindamycin Phosphate
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class II · Moderate risk Ongoing
Lidocaine HCL 1%
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Ongoing
Moxifloxacin 5mg/ml
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.