Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
CGMP Deviations
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
Rufinamide Tablets 200mg
CGMP Deviations
Class II · Moderate risk
Frovatriptan Succinate Tablets 2.5mg
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets 200mg
CGMP Deviations
Class II · Moderate risk
Gabapentin Tablets 600mg
CGMP Deviations
Class II · Moderate risk
Voriconazole Tablets 50mg
CGMP Deviations
Class II · Moderate risk
Voriconazole Tablets 200 mg
CGMP Deviations
Class II · Moderate risk
Solifenacin Succinate Tablets 10MG
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 325mg
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 225mg
CGMP Deviations
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
In Your Face Mineral Tint SPF 31
cGMP deviations
Class II · Moderate risk
GreenScreen
cGMP deviations
Class II · Moderate risk
Erin's Faces
cGMP deviations
Class II · Moderate risk
B Natural Organics
cGMP deviations
Class II · Moderate risk
Proactiv Skin Smoothing Exfoliator
Chemical contamination: Presence of benzene
Class II · Moderate risk
Proactiv Emergency Blemish Relief
Chemical contamination: Presence of benzene
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
CVS Health Concealing Acne Treatment Cream
Chemical contamination: presence of benzene
Class II · Moderate risk
Walgreens Maximum Strength Tinted Acne Treatment Cream 10%…
Chemical contamination: presence of benzene
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
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
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Sofosbuvir and Velpatasvir
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility