Class II · Moderate risk Ongoing
Aurobindo Ranitidine Caspules 150 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
DG Health Acid Reducer Ranitidine Tablets 150 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Maximum Strength Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Cool Mint Maximum Strength Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 150 mg Distributed by: Chattem
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Maximum Strength Zantac 150 mg Distributed by: Chattem
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class III · Low risk Ongoing
Ranitidine Tablets USP
Reason CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Class II · Moderate risk Ongoing
Losartan Potassium/ Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Class II · Moderate risk Ongoing
Losartan Potassium /Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Class II · Moderate risk Ongoing
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Ongoing
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Class II · Moderate risk Ongoing
Losartan Potassium Tablets USP 25 mg 50 tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets USP 50 mg 50 tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.