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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

1000

Past Year

303

Class I (Serious)

34

Most Recent

Nov 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 2201–2220 of 4747 recalls

Dymista Nasal Spray (Mylan) – Broken Glass Risk (2019)

Defective Container: Potential for broken glass in the neck area of the glass bottles.

Class IIModerate

FDAFeb 1, 2019Nationwide• Mylan Pharmaceuticals Inc.

Moxifloxacin Eye Drops (Lupin) – Impurity Concerns (2019)

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

FDAFeb 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Diltiazem HCl CD 360mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

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Class IIILow

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 300mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 180mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 120mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 240mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Bimatoprost Ophthalmic Solution (Lupin) – impurity specification (2019)

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

FDAJan 28, 2019Nationwide• Lupin Pharmaceuticals Inc.

BromSite Ophthalmic Solution (Sun Pharmaceutical) – sterility risk (2019)

Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.

Class IIModerate

FDAJan 24, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Irbesartan Hydrochlorothiazide Tablets (Prinston) – NDEA impurity (2019)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDAJan 18, 2019Nationwide• Prinston Pharmaceutical Inc

Irbesartan Tablets (Prinston) – NDEA impurity (2019)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDAJan 18, 2019Nationwide• Prinston Pharmaceutical Inc

Irbesartan Hydrochlorothiazide Tablets (Prinston) – NDEA impurity (2019)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDAJan 18, 2019Nationwide• Prinston Pharmaceutical Inc

Irbesartan Hydrochlorothiazide Tablets (Prinston) – NDEA impurity (2019)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDAJan 18, 2019Nationwide• Prinston Pharmaceutical Inc

Fexofenadine Tablets (Mylan) – impurity specification (2019)

Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.

Class IIModerate

FDAJan 18, 2019Nationwide• Mylan Pharmaceuticals Inc.

Irbesartan Hydrochlorothiazide Tablets (Prinston) – NDEA impurity (2019)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDAJan 18, 2019Nationwide• Prinston Pharmaceutical Inc

Losartan Potassium Tablets (Major) – impurity detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAJan 10, 2019Nationwide• MAJOR PHARMACEUTICALS

Cephalexin Oral Suspension (Lupin) – packaging issue (2019)

CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

Class IIModerate

FDAJan 9, 2019Nationwide• Lupin Pharmaceuticals Inc.

Cephalexin Oral Suspension (Lupin) – manufacturing record (2019)

CGMP Deviation; manufacturing batch record could not be located

Class IIModerate

FDAJan 7, 2019Nationwide• Lupin Pharmaceuticals Inc.

Vecuronium Bromide Injection 10mg (Sun) – glass contamination (2019)

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

FDAJan 3, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Vecuronium Bromide Injection 20mg (Sun) – glass contamination (2019)

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

FDAJan 3, 2019Nationwide• Sun Pharmaceutical Industries, Inc.