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Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. Recalls

All product recalls associated with Mylan Pharmaceuticals Inc..

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Recall Summary

Total Recalls

79

Past Year

1

Class I (Serious)

3

Most Recent

Feb 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 79 recalls

Valsartan Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan Tablets (Mylan) – impurity risk (2018)

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

Page 2 of 4Next

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan, Hydrochlorothiazide Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Valsartan Tablets (Mylan) – impurity risk (2018)

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

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Levonorgestrel Estradiol Tablets (Mylan) – Labeling Error (2018)

Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.

FDAAug 27, 2018Nationwide• Mylan Pharmaceuticals Inc.

Diltiazem HCl Capsules (Mylan) – Stability Test Failure (2018)

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

FDAAug 7, 2018Nationwide• Mylan Pharmaceuticals Inc.

Diltiazem HCl Capsules (Mylan) – Stability Test Failure (2018)

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

FDAAug 7, 2018Nationwide• Mylan Pharmaceuticals Inc.

Dymista Nasal Spray (Mylan) – glass contamination (2018)

Presence of foreign substance: Potential for glass in the neck area of the glass bottles.

Class IIModerate

FDAJul 25, 2018Nationwide• Mylan Pharmaceuticals Inc.

Triamterene and Hydrochlorothiazide (Mylan) – Subpotent Drug (2018)

Subpotent Drug

FDAJul 9, 2018Nationwide• Mylan Pharmaceuticals Inc.

Maxzide-25 (Mylan) – Slight Potency Variation (2018)

Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

FDAJun 7, 2018Nationwide• Mylan Pharmaceuticals Inc.

PrednisoLONE Sodium Tablets 30mg (Mylan) – Manufacturing Deviation (2018)

CGMP Deviations

Class IIModerate

FDAApr 30, 2018Nationwide• Mylan Pharmaceuticals Inc.

PrednisoLONE Sodium Tablets 10mg (Mylan) – Manufacturing Deviation (2018)

CGMP Deviations

Class IIModerate

FDAApr 30, 2018Nationwide• Mylan Pharmaceuticals Inc.

PrednisoLONE Sodium Tablets 15mg (Mylan) – Manufacturing Deviation (2018)

CGMP Deviations

Class IIModerate

FDAApr 30, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Benazapril Capsules (Mylan) – Manufacturing Deviation (2018)

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure

Class IIModerate

FDAApr 24, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Benazapril Capsules (Mylan) – Manufacturing Deviation (2018)

cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure

Class IIModerate

FDAApr 24, 2018Nationwide• Mylan Pharmaceuticals Inc.

Loxapine Capsules 25mg (Mylan) – Manufacturing Deviation (2018)

CGMP Deviations

Class IIModerate

FDAApr 24, 2018Nationwide• Mylan Pharmaceuticals Inc.