Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason Presence of Foreign Substance
Class I · High risk Terminated
Green Lumber Natural Fuel For Men capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts USP
Reason Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class III · Low risk Terminated
PF-Succinylcholine Chloride Injection
Reason Incorrect labeling: Incorrect or missing lot and/or exp date
Class II · Moderate risk Terminated
BIOGENYX True Full Spectrum CBD Oil Cinnamon
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
BIOGENYX True Full Spectrum CBD Oil Natural Flavor
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
BIOGENYX True Full Spectrum CBD Oil Wintergreen
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 2400
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz.
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Nuovi Firming Masque
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset Nuovi Skin Toner
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Miracle Facelift Masque
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Basic Reset Earth Wash Cleaner and Personal Care
Reason Marketed without an Approved NDA/ANDA
Class II · Moderate risk Terminated
Prasugrel Tablets 5 mg
Reason Failed Dissolution Specification: Low out of specification dissolution results.
Class II · Moderate risk Terminated
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution 0.5%
Reason Labeling: Incorrect or missing package insert.