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 1–20 of 79 recalls

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

Failed Dissolution Specifications - low dissolution results

Class IIModerate

FDAFeb 25, 2025Nationwide• MYLAN PHARMACEUTICALS INC

Insulin Glargine (Mylan) – Missing Medication Label (2022)

Labeling: Missing label: Label missing from some prefilled pens.

Class IHigh

FDAJul 5, 2022Nationwide• Mylan Pharmaceuticals Inc

Insulin Glargine (Mylan) – Missing Label (2022)

Labeling: Missing label on the vial

Class IHigh

FDA

Apr 12, 2022

Nationwide

• Mylan Pharmaceuticals Inc

Rifampin Injection (Mylan) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.

Class IIModerate

FDAApr 7, 2022Nationwide• Mylan Pharmaceuticals Inc

Travoprost Ophthalmic Solution (Mylan) – Subpotent Medication (2022)

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.

Class IIModerate

FDAApr 1, 2022Nationwide• Mylan Pharmaceuticals Inc

Proctofoam HC (Mylan) – cGMP Deficiencies (2022)

cGMP deficiencies

Class IIModerate

FDAJan 21, 2022Nationwide• Mylan Pharmaceuticals Inc

Semglee Insulin (Mylan) – Missing Label (2022)

Labeling: Missing Label: label missing from some Semglee prefilled pens.

Class IHigh

FDAJan 5, 2022Nationwide• Mylan Pharmaceuticals Inc

Candesartan-Hydrochlorothiazide Tablets (Mylan) – Impurity Issue (2020)

Out-of-specification organic impurity results obtained during routine stability testing.

Class IIILow

FDAOct 2, 2020Nationwide• Mylan Pharmaceuticals Inc.

Tacrolimus Capsules (Mylan Pharmaceuticals) – Foreign Tablet Risk (2020)

Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

Class IIILow

FDAMar 23, 2020Nationwide• Mylan Pharmaceuticals Inc.

Sotalol HCL Tablets (Mylan) – Metal Particle Contamination (2020)

Presence of particulate matter. presence of metal particles.

Class IIModerate

FDAMar 9, 2020Nationwide• Mylan Pharmaceuticals Inc.

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Class IIModerate

FDAJan 7, 2020Nationwide• Mylan Pharmaceuticals Inc.

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Class IIModerate

FDAJan 7, 2020Nationwide• Mylan Pharmaceuticals Inc.

Alprazolam Tablets (Mylan) – foreign substance risk (2019)

Presence of Foreign Substance

Class IIModerate

FDAOct 23, 2019Nationwide• Mylan Pharmaceuticals Inc.

Prasugrel Tablets (Mylan) – Dissolution Failure (2019)

Failed Dissolution Specification: Low out of specification dissolution results.

Class IIModerate

FDAOct 18, 2019Nationwide• Mylan Pharmaceuticals Inc.

Gatifloxacin Eye Solution (Mylan) - impurity specification (2019)

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

Class IIILow

FDASep 6, 2019Nationwide• Mylan Pharmaceuticals Inc.

Diltiazem Capsules (Mylan) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Class IIILow

FDAFeb 13, 2019Nationwide• Mylan Pharmaceuticals Inc.

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.

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.

Toxinout Kit (DrNatura) – product quality issue (2018)

Undeclared Allergen

Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement.

Class IIModerate

FDADec 10, 2018Nationwide• Mylan Pharmaceuticals Inc.

Flora Protect Probiotics (DrNatura) – product issue (2018)

Undeclared Allergen

Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are being recalled due to undeclared soy allergen statement.

Class IIModerate

FDADec 10, 2018Nationwide• Mylan Pharmaceuticals Inc.

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MYLAN PHARMACEUTICALS INC Recalls

Recall Summary

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

Insulin Glargine (Mylan) – Missing Medication Label (2022)

Insulin Glargine (Mylan) – Missing Label (2022)

Rifampin Injection (Mylan) – Impurity Specification (2022)

Travoprost Ophthalmic Solution (Mylan) – Subpotent Medication (2022)

Proctofoam HC (Mylan) – cGMP Deficiencies (2022)

Semglee Insulin (Mylan) – Missing Label (2022)

Candesartan-Hydrochlorothiazide Tablets (Mylan) – Impurity Issue (2020)

Tacrolimus Capsules (Mylan Pharmaceuticals) – Foreign Tablet Risk (2020)

Sotalol HCL Tablets (Mylan) – Metal Particle Contamination (2020)

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

Alprazolam Tablets (Mylan) – foreign substance risk (2019)

Prasugrel Tablets (Mylan) – Dissolution Failure (2019)

Gatifloxacin Eye Solution (Mylan) - impurity specification (2019)

Diltiazem Capsules (Mylan) – Impurity Specification (2019)

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

Fexofenadine Tablets (Mylan) – impurity specification (2019)

Toxinout Kit (DrNatura) – product quality issue (2018)

Flora Protect Probiotics (DrNatura) – product issue (2018)