Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
niCARdipine Hydrochloride Injection
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing
niCARdipine Hydrochloride Injection
Reason Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II · Moderate risk Ongoing
Clindamycin Hydrochloride Capsules
Reason cGMP Deviations
Class I · High risk Ongoing
Ropivacaine Hydrochloride Injection
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
FentaNYL 500mcg
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexonto 0.4%
Reason Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class III · Low risk Terminated
HYDROmorphone Hydrochloride 50mg/50mL
Reason Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class II · Moderate risk Terminated
Urodel
Reason cGMP deviations
Class II · Moderate risk Terminated
Rapidol Arnica Tablets
Reason cGMP deviations
Class II · Moderate risk Terminated
Rapidol Arnica Gel
Reason cGMP deviations
Class II · Moderate risk Terminated
Kingskin
Reason cGMP deviations
Class II · Moderate risk Terminated
DoloEar Earache Drops
Reason cGMP deviations
Class II · Moderate risk Terminated
DoloDent Maximum Strength Toothache Drops
Reason cGMP deviations
Class I · High risk Ongoing
Male Ultra Pro
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Ultra Armor
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Electro Buzz
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Class I · High risk Ongoing
Malextra
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Male Ultra
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
ChlorproMAZINE Hydrochloride Tablets
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent