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Teva Pharmaceuticals USA

Teva Pharmaceuticals USA Recalls

All product recalls associated with Teva Pharmaceuticals USA.

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Recall Summary

Total Recalls

266

Past Year

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 181–200 of 266 recalls

Amoxicillin Suspension (Teva) – Subpotency Concern (2016)

Subpotency: due to a low, out of specification test result for assay during stability testing.

Class IIModerate

FDADec 21, 2016Nationwide• Teva Pharmaceuticals USA

Risedronate Sodium Tablets (Teva) – Failed Dissolution (2016)

Failed Dissolution Specifications

Class IIILow

FDADec 1, 2016Nationwide• Teva Pharmaceuticals USA

Qnasl Nasal Aerosol 40mcg (Teva) – Content Uniformity (2016)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Class III

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Low

FDANov 1, 2016Nationwide• Teva Pharmaceuticals USA

Qnasl Nasal Aerosol 80mcg (Teva) – Content Uniformity (2016)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Class IIILow

FDANov 1, 2016Nationwide• Teva Pharmaceuticals USA

Paricalcitol 2mcg Capsules (Teva) – impurity specs (2016)

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Class IIILow

FDASep 22, 2016Nationwide• Teva Pharmaceuticals USA

Paricalcitol 1mcg Capsules (Teva) – impurity specs (2016)

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Class IIILow

FDASep 22, 2016Nationwide• Teva Pharmaceuticals USA

Paricalcitol 4mcg Capsules (Teva) – impurity specs (2016)

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Class IIILow

FDASep 22, 2016Nationwide• Teva Pharmaceuticals USA

mitoXANTRONE Injection (Teva) – Impurities Specification Failure (2016)

Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

Class IIILow

FDASep 13, 2016Nationwide• Teva Pharmaceuticals USA

Amikacin Sulfate Injection (Teva) – CGMP Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJul 29, 2016Nationwide• Teva Pharmaceuticals USA

Amikacin Sulfate Injection (Teva) – CGMP Deviation (2016)

CGMP Deviations

Class IIModerate

FDAJul 29, 2016Nationwide• Teva Pharmaceuticals USA

Amikacin Sulfate Injection (Teva) – Glass Particulate (2016)

Presence of Particulate Matter: particulate matter identified as glass in one vial.

Class IHigh

FDAMar 9, 2016Nationwide• Teva Pharmaceuticals USA

Paricalcitol Capsules (Teva) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.

Class IIModerate

FDAFeb 5, 2016Nationwide• Teva Pharmaceuticals USA

Nabumetone 750mg Tablets (Teva) – Labeling Issue (2015)

Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.

Class IIILow

FDANov 19, 2015Nationwide• Teva Pharmaceuticals USA

Dextroamphetamine Tablets (Teva) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

Class IIModerate

FDANov 12, 2015Nationwide• Teva Pharmaceuticals USA

Adrucil (Teva Pharmaceuticals) – particulate matter risk (2015)

Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution

Class IHigh

FDAJul 24, 2015Nationwide• Teva Pharmaceuticals USA

Dextroamphetamine Combination (Teva) – impurity specification (2015)

Failed Impurities/Degradation Specifications: out of specification for unknown impurity

Class IIModerate

FDAJun 24, 2015Nationwide• Teva Pharmaceuticals USA

Zebeta Tablets (Teva) – Dissolution Specification Failure (2015)

Failed Dissolution Specifications: OOS result during stability testing

Class IIModerate

FDAMay 11, 2015Nationwide• Teva Pharmaceuticals USA

QVAR Inhalation Aerosol (Teva) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.

Class IIILow

FDAMay 7, 2015Nationwide• Teva Pharmaceuticals USA

Adrucil Injection (Teva) – Particulate Matter Contamination (2015)

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Class IHigh

FDAApr 28, 2015Nationwide• Teva Pharmaceuticals USA

Fluoxetine Capsules 20mg (Teva) – Chemical Contamination (2015)

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

Class IIModerate

FDAApr 13, 2015Nationwide• Teva Pharmaceuticals USA