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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

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 3881–3900 of 4747 recalls

Fluvastatin Capsules (Teva) – failed specifications (2014)

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.

Class IIModerate

FDAMay 29, 2014Nationwide• Teva Pharmaceuticals USA

Foradil Aerolizer (Novartis) – failed stability test (2014)

Failed Stability Specification; out of specification result for particle size distribution during stability testing

Class IIILow

FDAMay 28, 2014Nationwide• Novartis Pharmaceuticals Corp.

Ciprofloxacin Tablets (Aidarex) – foreign tablet mix-up (2014)

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

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Class IIModerate

FDAMay 22, 2014Nationwide• Aidarex Pharmaceuticals LLC

Vasotec Tablets (Valeant) – incorrect package insert (2014)

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

Class IIILow

FDAMay 21, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Vaseretic Tablets (Valeant) – incorrect package insert (2014)

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset

Class IIILow

FDAMay 21, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Isoniazid Tablets (West-Ward) – dissolution failure (2014)

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

Class IIModerate

FDAMay 20, 2014Nationwide• West-Ward Pharmaceutical Corp.

Bystolic (Forest Pharmaceuticals) – dissolution failure (2014)

Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.

Class IIModerate

FDAMay 12, 2014Nationwide• Forest Pharmaceuticals Inc

Promethazine Tablets (Zydus) – Foreign Tablet Mix (2014)

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Class IIModerate

FDAMay 8, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Hemo-Stat Solution (Axcentria) – Unauthorized Distribution (2014)

Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

Class IIModerate

FDAMay 5, 2014Nationwide• Axcentria Pharmaceuticals, LLC

Dextroamphetamine Tablets (Teva) – Impurity Specifications (2014)

Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.

Class IIModerate

FDAMay 1, 2014Nationwide• Teva Pharmaceuticals USA

TEV-TROPIN Injection (Ferring) – Silicone Oil Contamination (2014)

Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.

Class IIModerate

FDAApr 28, 2014PA• Ferring Pharmaceuticals Inc

QVAR Inhalation Aerosol (Teva) – Defective Valve (2014)

Defective Delivery System; defective valve

Class IIModerate

FDAApr 23, 2014Nationwide• Teva Pharmaceuticals USA

Glycopyrrolate Syringe (Pharmakon) – Undeclared Benzyl Alcohol (2014)

Undeclared Allergen

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Class IIModerate

FDAApr 21, 2014Nationwide• Pharmakon Pharmaceuticals

Midazolam HCl Vial (Pharmakon) – Undeclared Benzyl Alcohol (2014)

Undeclared Allergen

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Class IHigh

FDAApr 21, 2014Nationwide• Pharmakon Pharmaceuticals

Midazolam HCl IV (Pharmakon) – Undeclared Benzyl Alcohol (2014)

Undeclared Allergen

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Class IHigh

FDAApr 21, 2014Nationwide• Pharmakon Pharmaceuticals

Atropine Sulfate Injection (Pharmakon) – undeclared benzyl alcohol (2014)

Undeclared Allergen

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Class IHigh

FDAApr 21, 2014Nationwide• Pharmakon Pharmaceuticals

Cubicin Injection (Cubist) – glass shard contamination (2014)

Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.

Class IHigh

FDAApr 17, 2014Nationwide• Cubist Pharmaceuticals, Inc.

Pristiq Tablets (Pfizer) – foreign tablet mix-up (2014)

Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.

Class IIModerate

FDAApr 16, 2014Nationwide• Pfizer Us Pharmaceutical Group

Children's Cetirizine Chewables (Caraco) – impurity issue (2014)

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Class IIILow

FDAApr 9, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Pantoprazole Sodium Tablets (Legacy) – packaging error (2014)

Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets

Class IIModerate

FDAApr 9, 2014IN• Legacy Pharmaceutical Packaging