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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 61–79 of 79 recalls

Amlodipine Besylate Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Ciprofloxacin Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

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Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Benazepril Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Ciprofloxacin Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Tablets 10mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Lamotrigine Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Ropinirole Tablets (Mylan) – Incorrect Labeling (2013)

Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..

Class IIModerate

FDAApr 22, 2013Nationwide• Mylan Pharmaceuticals Inc.

Lisinopril Tablets (Mylan) – Incorrect Imprint (2013)

Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..

FDAFeb 26, 2013Nationwide• Mylan Pharmaceuticals Inc.

Lansoprazole Capsules (Mylan) – Foreign Tablet Contamination (2013)

Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.

Class IIModerate

FDAJan 30, 2013Nationwide• Mylan Pharmaceuticals Inc.

Carvedilol Tablets 12.5mg (Mylan) – Tablet Weight Issue (2013)

Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.

Class IIModerate

FDAJan 16, 2013Nationwide• Mylan Pharmaceuticals Inc.

Doxazosin Tablets (Mylan) – Product Cross Contamination (2012)

Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.

Class IIModerate

FDAAug 7, 2012Nationwide• Mylan Pharmaceuticals Inc.

Levetiracetam Tablets (Mylan) – Foreign Tablet Presence (2012)

Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.

Class IIModerate

FDAJul 27, 2012KY• Mylan Pharmaceuticals Inc.

Famotidine Tablets (Mylan) – Impurity Concern (2012)

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

FDAJun 28, 2012Nationwide• Mylan Pharmaceuticals Inc.