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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

304

Class I (Serious)

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 3861–3880 of 4747 recalls

Metoprolol Succinate Tablets (Mylan) – Foreign Tablet Contamination (2014)

Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Class IIModerate

FDAJul 3, 2014Nationwide• Mylan Pharmaceuticals Inc.

Triamcinolone Acetonide Lotion 0.025% (Fougera) – pH Specification Issue (2014)

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Class IIILow

FDAJul 3, 2014Nationwide• Fougera Pharmaceuticals Inc.

E-Z-HD Barium Sulfate (Bracco) – Subpotent Drug Concerns (2014)

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

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Class IIILow

FDAJul 2, 2014Nationwide• Bracco Diagnostic Inc

Cephalexin Capsules 500mg (Caraco) – Manufacturing Deviation (2014)

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Class IIModerate

FDAJun 26, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Cephalexin Capsules 250mg (Caraco) – Manufacturing Deviation (2014)

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Class IIModerate

FDAJun 26, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Poly-Tussin AC Liquid (Poly Pharmaceuticals) – Monograph Deviation (2014)

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Class IIILow

FDAJun 26, 2014Nationwide• Poly Pharmaceuticals, Inc

Lortuss EX Liquid (Poly Pharmaceuticals) – Monograph Deviation (2014)

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Class IIILow

FDAJun 26, 2014Nationwide• Poly Pharmaceuticals, Inc

Tolterodine Tartrate Tablets (Mylan) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.

Class IIILow

FDAJun 20, 2014Nationwide• Mylan Pharmaceuticals Inc.

Bystolic Tablets (Forest Pharmaceuticals) – Dissolution Failure (2014)

Failed Dissolution Specifications: Drug failed stage III dissolution testing.

Class IIModerate

FDAJun 19, 2014Nationwide• Forest Pharmaceuticals Inc

Diltiazem HCl Extended Release Capsules (Mylan) – Compound Failure (2014)

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

Class IIILow

FDAJun 19, 2014Nationwide• Mylan Pharmaceuticals Inc.

Apri (Teva) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Class IIILow

FDAJun 17, 2014Nationwide• Teva Pharmaceuticals USA

Mircette (Teva) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Class IIILow

FDAJun 17, 2014Nationwide• Teva Pharmaceuticals USA

Velivet (Teva) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Class IIILow

FDAJun 17, 2014Nationwide• Teva Pharmaceuticals USA

Kariva (Teva) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Class IIILow

FDAJun 17, 2014Nationwide• Teva Pharmaceuticals USA

Venlafaxine (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Class IIModerate

FDAJun 12, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

APLENZIN (Valeant) – Missing Package Insert (2014)

Labeling: Incorrect or Missing Package Insert

Class IIILow

FDAJun 5, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Carbidopa Levodopa (Teva) – Tablet Specification (2014)

Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.

Class IIModerate

FDAJun 5, 2014Nationwide• Teva Pharmaceuticals USA