Class II · Moderate risk
Regular Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Regular Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance
Class II · Moderate risk
Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Maximum Strength Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Cool Mint Maximum Strength Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 150 mg Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Maximum Strength Zantac 150 mg Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I · High risk
Green Lumber Natural Fuel For Men capsule
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
Estradiol Vaginal Inserts USP
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class III · Low risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class III · Low risk
PF-Succinylcholine Chloride Injection
Incorrect labeling: Incorrect or missing lot and/or exp date
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Cinnamon
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Natural Flavor
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
BIOGENYX True Full Spectrum CBD Oil Wintergreen
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 2400
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz.
Marketed without an Approved NDA/ANDA
Class II · Moderate risk
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon
Marketed without an Approved NDA/ANDA