Class I · High risk
Weiner Boner Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class I · High risk
Spanish Fly 22K capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class II · Moderate risk
Infumorph (Preservative-free Morphine Sulfate Sterile Solution)
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
Treprostinil Injection
Presence of Particulate Matter.
Class II · Moderate risk
Febuxostat Tablets 80mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
FentaNYL citrate
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
hyalogic For Dry Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Red Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Pink Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Aging Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Floaters Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Eye strain Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Dryness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Eye Twitching Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Blur Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Allergy Eyes Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Methylprednisolone acetate Injectable Suspension
Failed Dissolution Specifications
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk
Clindamycin Phosphate
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class II · Moderate risk
Lidocaine HCL 1%
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin 5mg/ml
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.