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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)

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 4001–4020 of 4747 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 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.

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.

Risperdal CONSTA (Janssen) – Non-Sterility Risk (2013)

Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

Class IIModerate

FDASep 11, 2013Nationwide• Janssen Pharmaceuticals, Inc.

Motorcycle Training Wheels (Cambridge) – Crash Hazard (2013)

The recalled products are Moose Racing brand training wheels for youth motorcycles and the replacement wheel kit. The training wheels have a black, one-piece, full-length metal axle with a plate that attaches to the underside of the motorcycle frame beneath the engine and two inflatable rubber wheels. The Moose Racing logo appears on the left and right sides of the axle. The replacement wheel kit is a set of two tires mounted on the wheel assembly. Replacement wheel kits and training wheels that fit the following youth motorcycle models are being recalled: Honda XR/CRF 50, Kawasaki KDX/Suzuki JR 50, KTM 50, Suzuki DRZ 70, Yamaha PW50 and Yamaha TTR 50.

CPSCSep 11, 2013Nationwide• Cambridge Metals & Plastics, a Division of Water Works Manufacturing Inc., of Cambridge, Minn.

Timolol Maleate Ophthalmic Solution (PACK) – Defective Container (2013)

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

FDASep 9, 2013Nationwide• PACK Pharmaceuticals, LLC

Timolol Maleate Ophthalmic Solution (PACK) – Defective Container (2013)

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

FDASep 9, 2013Nationwide• PACK Pharmaceuticals, LLC

Ofloxacin Ophthalmic Solution (PACK) – Defective Container (2013)

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

FDASep 9, 2013Nationwide• PACK Pharmaceuticals, LLC

Timolol Maleate Ophthalmic Solution (PACK) – Defective Container (2013)

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

FDASep 9, 2013Nationwide• PACK Pharmaceuticals, LLC

Timolol Maleate Ophthalmic Solution (PACK) – Defective Container (2013)

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

FDASep 9, 2013Nationwide• PACK Pharmaceuticals, LLC

Ofloxacin Ophthalmic Solution (PACK) – Defective Container (2013)

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

FDASep 9, 2013Nationwide• PACK Pharmaceuticals, LLC

Derma-Smoothe/FS Body Oil (Hill Dermaceuticals) – Subpotent Drug (2013)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDASep 8, 2013Nationwide• Hill Dermaceuticals, Inc.

Derma-Smoothe/FS Scalp Oil (Hill Dermaceuticals) – Subpotent Drug (2013)

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

FDASep 8, 2013Nationwide• Hill Dermaceuticals, Inc.

Carboxymethylcellulose Sodium Eye Solution (Altaire) – Mold Contamination (2013)

Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.

FDASep 6, 2013Nationwide• Altaire Pharmaceuticals, Inc.

Aldactone Tablets (Pfizer) – Dissolution Profile Issue (2013)

Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

Class IIModerate

FDASep 4, 2013Nationwide• Pfizer Us Pharmaceutical Group

Cubicin Injection (Cubist) – Glass Particulates (2013)

Presence of Particulate Matter; Glass particulates observed in vials

FDAAug 29, 2013Nationwide• Cubist Pharmaceuticals, Inc.

Bupropion Tablets (Actavis) – Dissolution Failure (2013)

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

FDAAug 21, 2013Nationwide• Actavis South Atlantic LLC

Ducal Prepared Sauce Queso (Kern's) – pH Level Concern (2013)

Lab analysis detected the pH to be greater than 4.4

Class IIModerate

FDAAug 20, 2013CO, IN, LA +3 more• Industrias Alimenticias Kern's y Cia. S.C.A.