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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

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 881–900 of 4747 recalls

Neomycin Sulfate Tablets (Teva) – CGMP Deviations (2022)

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

Class IIModerate

FDAAug 23, 2022Nationwide• Teva Pharmaceuticals USA Inc

Dimension Magnesium Test (Siemens) – Quality Control Problem (2022)

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

FDAAug 17, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

PTS Cholesterol Strips (PTS Diagnostics) – Instructions Error (2022)

1...43 444546 47...238

Page 45 of 238Next

Incorrect instructions for use were packaged into the final product.

FDAAug 16, 2022Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

IMMULITE Thyroid Test (Siemens) – Negative Bias (2022)

An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid

FDAAug 11, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Vitamin Herb Blend (Eclectic Institute) – Ingredient Mislabeling (2022)

Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel.

Class IIILow

FDAAug 3, 2022Nationwide• Eclectic Institute Inc

Zynrelef (Heron Therapeutics) – Defective Syringe (2022)

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

Class IIILow

FDAAug 2, 2022Nationwide• HERON THERAPEUTICS, INC.

Aesop Post-Poo Drops (Emeis Cosmetics) – child safety risk (2022)

Fire/Burn Risk

This recall involves Aesop Post-Poo Drops, a bathroom deodorizer in a 100 mL amber glass bottle, with a continuous thread pipette dispenser closure. The bottle has a black and cream label with the brand name Aesop. The UPC number 9319944009200 is located on the rear of the bottle, directly below the ingredients list. The deodorizer product was also sold in four versions of the Home Kit: The Protector, The Seasoned Wayfarer, The Melodist, and The Familiar Horizon. The UPC numbers for four versions of the Home Kit are located on the rear of the printed sleeve. Only the Aesop Post-Poo Drops in the kit are included in this recall. The product names and UPC are as follows: Product Name UPC Description Post-Poo Drops 9319944009200 100 mL amber glass bottle, with a continuous thread pipette dispenser closure The Protector 9319944030198 100 mL amber glass bottle, with a continuous thread pipette dispenser closure The Seasoned Wayfarer 9319944023794 100 mL amber glass bottle, with a continuous thread pipette dispenser closure The Melodist 9319944022278 100 mL amber glass bottle, with a continuous thread pipette dispenser closure The Familiar Horizon 9319944016017 100 mL amber glass bottle, with a continuous thread pipette dispenser closure. This recall also involves four Aesop Oil Burner Blends: Anouk, Beatrice, Catherine, and Isabelle. The aromatic oil blends intended to be used in an oil burner. These products include a black and cream label with the brand name Aesop and the blend name. They come in a 25 mL amber glass bottle with a continuous thread closure and flow restrictor insert. The UPC numbers for the Oil Burner Blends are located on the rear of each bottle, below the ingredients lists. The product names and UPC for the recalled Oil Burner Blend products are as follows: Product Name UPC Description Anouk Oil Burner Blend 9319944000696 25 mL amber glass bottle with a continuous thread closure and flow restrictor insert Beatrice Oil Burner Blend 9319944000702 25 mL amber glass bottle with a continuous thread closure and flow restrictor insert Catherine Oil Burner Blend 9319944000689 25 mL amber glass bottle with a continuous thread closure and flow restrictor insert Isabelle Oil Burner Blend 9319944016871 25 mL amber glass bottle with a continuous thread closure and flow restrictor insert

CPSCJul 28, 2022Nationwide• Emeis Cosmetics Pty Ltd., of Collingwood, Victoria, Australia

Rifampin Capsules (Lupin) – Impurity Detected (2022)

CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.

Class IIModerate

FDAJul 28, 2022Nationwide• Lupin Pharmaceuticals Inc.

Divalproex Sodium Tablets (Amneal) – Dissolution Failure (2022)

Failed dissolution specifications.

Class IIModerate

FDAJul 27, 2022Nationwide• Amneal Pharmaceuticals of New York, LLC

Bupivacaine Lidocaine Solution (Pine) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 27, 2022AL, CA, IN +2 more• Pine Pharmaceuticals, LLC

Pantoprazole Sodium Suspension (Sun Pharmaceutical) – Discoloration (2022)

Discoloration

Class IIModerate

FDAJul 25, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Azacitidine Injection (Teva) – Subpotent Medication (2022)

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Class IIILow

FDAJul 22, 2022IN, OH• Teva Pharmaceuticals USA Inc

Matzim LA (Teva) – Dissolution Specification Failure (2022)

Failed Dissolution Specifications: below specification limits for dissolution.

Class IIModerate

FDAJul 21, 2022Nationwide• Teva Pharmaceuticals USA Inc

Matzim LA Tablets (Teva) – Dissolution Failure (2022)

Failed Dissolution Specifications: below specification limits for dissolution.

Class IIModerate

FDAJul 21, 2022Nationwide• Teva Pharmaceuticals USA Inc

VITROS XT 7600 System (Ortho-Clinical) – Electrical Current Shift (2022)

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

FDAJul 19, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT 3400 System (Ortho-Clinical) – Electrical Current Shift (2022)

FDAJul 19, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Irbesartan Tablets (Jubilant Cadista) – Dissolution Failure (2022)

Failed Dissolution Specifications

Class IIModerate

FDAJul 18, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Irbesartan Tablets (Jubilant Cadista) – Dissolution Failure (2022)

Failed dissolution specifications.

Class IIModerate

FDAJul 18, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Dimension Vista LOCI CA 15-3 (Siemens) – Sample Bias Risk (2022)

Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

FDAJul 18, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Fulvestrant Injection (Zydus) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJul 15, 2022Nationwide• Zydus Pharmaceuticals (USA) Inc