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

559 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

Valsartan and Hydrochlorothiazide Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6323-77 D-0330-2019
Class II · Moderate risk

Valsartan and Hydrochlorothiazide Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6322-77 D-0329-2019
Class II · Moderate risk

Valsartan and Hydrochlorothiazide Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6321-77 D-0328-2019
Class II · Moderate risk

Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5815-77 D-0327-2019
Class II · Moderate risk

Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5814-77 D-0326-2019
Class II · Moderate risk

Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5813-77 D-0325-2019
Class II · Moderate risk

Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5807-93 D-0324-2019
Class II · Moderate risk

Amlodipine and Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-1724-93 D-0323-2019
Class II · Moderate risk

Amlodipine and Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-1723-93 D-0322-2019
Class II · Moderate risk

Amlodipine and Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-1722-93 D-0321-2019
Class II · Moderate risk

Amlodipine and Valsartan Tablets

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-1721-93 D-0320-2019
Class II · Moderate risk

Amlodipine

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0093-7809-56 D-0310-2019
Class II · Moderate risk

Amlodipine

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0093-7960-56 D-0309-2019
Class II · Moderate risk

Amlodipine

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0093-7810-56 D-0308-2019
Class II · Moderate risk

Amlodipine

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0093-7807-56 D-0307-2019
Class II · Moderate risk

Amlodipine and Valsartan Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Pharmaceuticals Inc. NDC 0378-1724-93 D-0318-2019
Class II · Moderate risk

Valsartan and Hydrochlorothiazide Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Pharmaceuticals Inc. NDC 0378-6325-05 D-0317-2019
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Pharmaceuticals Inc. NDC 0378-5815-77 D-0316-2019
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Pharmaceuticals Inc. NDC 0378-5807-93 D-0315-2019
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Pharmaceuticals Inc. NDC 0378-5814-77 D-0314-2019
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Ongoing Nitrosamine impurity Mylan Pharmaceuticals Inc. NDC 0378-5813-77 D-0313-2019

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