Class III · Low risk
HYDROmorphone Hydrochloride 50mg/50mL
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class II · Moderate risk
Urodel
cGMP deviations
Class II · Moderate risk
Rapidol Arnica Tablets
cGMP deviations
Class II · Moderate risk
Rapidol Arnica Gel
cGMP deviations
Class II · Moderate risk
Kingskin
cGMP deviations
Class II · Moderate risk
DoloEar Earache Drops
cGMP deviations
Class II · Moderate risk
DoloDent Maximum Strength Toothache Drops
cGMP deviations
Class I · High risk
Male Ultra Pro
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Ultra Armor
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Electro Buzz
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Class I · High risk
Malextra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Male Ultra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
ChlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
clomiPRAMINE hydrochloride Capsules USP
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk
Wegovy (semaglutide)
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Class II · Moderate risk
Kapsin Ointment
CGMP Deviations
Class II · Moderate risk
Hemopropin Ointment
CGMP Deviations
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit