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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

303

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 2101–2120 of 4747 recalls

Losartan Potassium 100mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide• Teva Pharmaceuticals USA

Skeletal Kinetics, Llc: OsteoVation, Inject Bone Filler Kits, 5cc (part number 39...

A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.

FDAJun 6, 2019Nationwide• Skeletal Kinetics, Llc

Wal-Fex D (Sun Pharmaceutical) – Impurity Specification Failure (2019)

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

1...104 105106107 108...238

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Class IIModerate

FDAJun 5, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Allergy Relief D (Sun Pharmaceutical) – Impurity Specification Failure (2019)

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Class IIModerate

FDAJun 5, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Allergy Relief D (Sun Pharmaceutical) – Impurity Specification Failure (2019)

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Class IIModerate

FDAJun 5, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Wal-Fex D (Sun Pharmaceutical) – Impurity Specification Failure (2019)

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Class IIModerate

FDAJun 5, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

Roche Diagnostics Corporation: The Tina-quant lgA Gen.2 is an immunoturbidimetric assay....

Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.

FDAJun 3, 2019AL, IN, KY• Roche Diagnostics Corporation

Estradiol Vaginal Inserts (Glenmark) – Defective Delivery System (2019)

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Class IIModerate

FDAJun 3, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Siemens Healthcare Diagnostics Inc: Stratus CS Acute Care cTNI TestPak, SMN 10445071 Produ...

Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

FDAMay 29, 2019Nationwide• Siemens Healthcare Diagnostics Inc

Obalon Therapeutics Inc: Obalon Balloon System with Model 4300 Touch Dispenser Tou...

During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

FDAMay 23, 2019Nationwide• Obalon Therapeutics Inc

Cefdinir Oral Suspension (Lupin) – metal contamination (2019)

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

Class IIModerate

FDAMay 23, 2019Nationwide• Lupin Pharmaceuticals Inc.

Havoc ROV (Arctic Cat) – Crash Hazard (2019)

This recall involves all model year 2018 and 2019 Textron Havoc recreational off-highway vehicles manufactured by Arctic Cat. The two-seat vehicles come in four color combinations: charcoal metallic/bronze, green/black, red/black or white/black. The vehicles have Textron Off Road printed on each side of the hood and Havoc on each side of the rear cargo box.

CPSCMay 22, 2019Nationwide• Arctic Cat Inc., of Thief River Falls, Minn., a subsidiary of Textron Specialized Vehicles, of Augusta, Ga.

Prochlorperazine Edisylate Injection (Heritage) – Non-Sterility Risk (2019)

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

Class IHigh

FDAMay 21, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Amikacin Sulfate Injection (Heritage) – microbial growth (2019)

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

Class IHigh

FDAMay 21, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Amitiza Capsules (Mallinckrodt) – Label Mix-up (2019)

Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.

Class IIModerate

FDAMay 13, 2019Nationwide• MALLINCKRODT PHARMACEUTICALS