Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Regular Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Regular Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Regular Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Regular Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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.