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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 1161–1180 of 4747 recalls

Metoclopramide Injection (Teva) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 29, 2021Nationwide• Teva Pharmaceuticals USA

Vecuronium Bromide Injection (Teva) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 29, 2021Nationwide• Teva Pharmaceuticals USA

Adenosine Injection (Teva) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

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Page 59 of 238Next

FDA

Jul 29, 2021

Nationwide

• Teva Pharmaceuticals USA

Versea Diagnostics LLC: Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood...

Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

FDAJul 27, 2021Nationwide• Versea Diagnostics LLC

Versea Diagnostics LLC: CareStart COVID-19 Antigen Rapid Diagnostic Test for the ...

Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

FDAJul 27, 2021Nationwide• Versea Diagnostics LLC

Versea Diagnostics LLC: Status COVID-19/Flu Rapid Immunoassay for Direct Detectio...

Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

FDAJul 27, 2021Nationwide• Versea Diagnostics LLC

Versea Diagnostics LLC: FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative de...

Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

FDAJul 27, 2021Nationwide• Versea Diagnostics LLC

BioMimetic Therapeutics, LLC: AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

The kit contains the wrong vial tray in the package.

FDAJul 23, 2021Nationwide• BioMimetic Therapeutics, LLC

BioFire Diagnostics, LLC: FilmArray Blood Culture Identification (BCID) Panel Prod...

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

FDAJul 20, 2021Nationwide• BioFire Diagnostics, LLC

Micro Therapeutics Inc: Pipeline Flex Embolization Device

Laceration Risk

Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

FDAJul 13, 2021AL, AK, AZ +46 more• Micro Therapeutics Inc

Micro Therapeutics Inc: EV3 Pipeline Flex Embolization Device with Flex Shield Te...

Laceration Risk

Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

FDAJul 13, 2021AL, AK, AZ +46 more• Micro Therapeutics Inc

PROCEPT BIOROBOTICS CORPORATION: AQUABEAM Handpiece, REF: HP2000, a sterile single-use com...

Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

FDAJul 9, 2021Nationwide• PROCEPT BIOROBOTICS CORPORATION

AOD-9604 Injection (Innoveix) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 9, 2021Nationwide• Innoveix Pharmaceuticals Inc

Semorelin/Ipamorelin Injection (Innoveix) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 9, 2021Nationwide• Innoveix Pharmaceuticals Inc

Siemens Healthcare Diagnostics, Inc: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro di...

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

FDAJul 6, 2021Nationwide• Siemens Healthcare Diagnostics, Inc

Zeltiq Aesthetics, Inc: CoolSculpting Elite System The CoolSculpting System SW re...

An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.

FDAJul 5, 2021AL, AZ, AR +41 more• Zeltiq Aesthetics, Inc

Roche Diagnostics Operations, Inc.: cobas infinity central lab running software version 3.01....

Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.

FDAJun 24, 2021Nationwide• Roche Diagnostics Operations, Inc.

Leukine Injection (Partner Therapeutics) – Stability Failure (2021)

FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

Class IIILow

FDAJun 23, 2021Nationwide• Partner Therapeutics Inc

QiYu Hand Sanitizer (HOYU) – Subpotent Formulation (2021)

Subpotent

Class IIModerate

FDAJun 22, 2021Nationwide• HOYU(US) LOGISTICS INC

Topotecan Injection (Teva) – Particulate Matter (2021)

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

Class IHigh

FDAJun 18, 2021Nationwide• Teva Pharmaceuticals USA