Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
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 II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class II · Moderate risk
Unisom
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Class II · Moderate risk
Carvedilol Tablets USP 25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 12.5 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 6.25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Walgreens
Chemical Contamination: Presence of benzene
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications - low dissolution results
Class III · Low risk
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class II · Moderate risk
Zapzyt
Chemical Contamination: Presence of benzene.
Class I · High risk
Vitality
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
CURAD Alcohol Prep Pads
Subpotent Drug
Class II · Moderate risk
Medline Alcohol Prep Pads
Subpotent Drug