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Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA, Inc. Recalls

All product recalls associated with Teva Pharmaceuticals USA, Inc..

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Recall Summary

Total Recalls

266

Past Year

6

Class I (Serious)

7

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 241–260 of 266 recalls

Methylphenidate Extended-Release (Teva) – dissolution failure (2013)

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Class IIModerate

FDAJun 18, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Methylphenidate Extended-Release (Teva) – dissolution failure (2013)

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Class IIModerate

FDAJun 18, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Amoxicillin Oral Suspension (Teva) – Orange Discoloration (2013)

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

Page 13 of 14Next

Class IIILow

FDAJun 18, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Actiq Fentanyl 200mcg (Teva Pharmaceuticals) – Failed Dissolution Test (2013)

Failed Dissolution Specification; during stability testing

Class IIModerate

FDAMay 28, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Amoxicillin Oral Suspension (Teva) – Powder Discoloration (2013)

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

FDAApr 26, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Disulfiram Tablets (Teva) – Missing Cotton Coil (2013)

CGMP Deviation; cotton coil is missing in some packaged bottles

FDAMar 19, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Lessina Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Balziva Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Junel Fe Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Errin Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Jolessa Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Camila Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

FDAMar 15, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Seasonale Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

FDAMar 14, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Camrese Tablets (Teva) – Impurity Specification Failure (2013)

Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing

FDAMar 14, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Portia Tablets (Teva) – Appearance Specification Failure (2013)

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

FDAMar 12, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Jolessa Tablets (Teva) – Appearance Specification Failure (2013)

Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.

FDAMar 12, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Cefdinir Suspension (Teva) – Improper Seal (2013)

Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.

Class IIModerate

FDAFeb 26, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Clonazepam Orally Disintegrating Tablets (Teva) – Content Uniformity (2013)

Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.

Class IIModerate

FDAFeb 7, 2013NC• Teva Pharmaceuticals USA, Inc.

Terazosin Capsules (Teva) – Foreign Capsule Found (2013)

Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.

Class IIModerate

FDAJan 23, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Copaxone (Teva) - visible metal contamination (2012)

Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.

Class IIModerate

FDADec 5, 2012Nationwide• Teva Pharmaceuticals USA, Inc.