Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

2,357 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Ongoing Stability / shelf life Wuhan Bingbing Pharmaceutical Co., Ltd. NDC 53225-1023-1 D-1278-2020
Class II · Moderate risk

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Ongoing Stability / shelf life Wuhan Bingbing Pharmaceutical Co., Ltd. NDC 10882-527-01 D-1277-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-3747-00 D-1102-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-3746-00 D-1101-2020
Class II · Moderate risk

Losartan Potassium Tablets

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-3745-00 D-1100-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Granules India Limited NDC 62207-773-32 D-0632-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 53746-254-02 D-0616-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 53746-253-10 D-0615-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 65162-254-30 D-0613-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 65162-253-06 D-0612-2020
Class II · Moderate risk

Ranitidine Syrup

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Ongoing Nitrosamine impurity AuroMedics Pharma LLC NDC 65862-431-74 D-0529-2020
Class II · Moderate risk

Zantac 75 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Ongoing Nitrosamine impurity Sanofi-Aventis U.S. LLC D-0545-2020
Class II · Moderate risk

Zantac 150 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Ongoing Nitrosamine impurity Sanofi-Aventis U.S. LLC D-0544-2020

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