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Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. Recalls

All product recalls associated with Ortho-Clinical Diagnostics, Inc..

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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 401–420 of 4747 recalls

VITROS Folate Reagent Pack (Ortho-Clinical) – Precipitation Issue (2024)

It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.

FDAJul 3, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

Class III

1...19 202122 23...238

Page 21 of 238Next

Low

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Micafungin Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Decitabine Injection (Sun Pharma) – Microbial Count Issue (2024)

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Class IIModerate

FDAJul 2, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Micafungin Injection (Zydus Pharmaceuticals) – Cross Contamination (2024)

Cross contamination with other products

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Fludrocortisone Acetate Tablets (Teva) – Impurity Concerns (2024)

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

Class IIModerate

FDAJun 28, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Pravastatin Sodium Tablets (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: results below specifications

Class IIModerate

FDAJun 28, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Cyanocobalamin Injection (Zydus) – Glass Particulate Risk (2024)

Presence of particulate matter: glass

Class IIModerate

FDAJun 27, 2024TN• Zydus Pharmaceuticals (USA) Inc

SinuFrin Nasal Decongestant (Neilmed) – Sub-Potent Drug (2024)

Sub-potent Drug

Class IIILow

FDAJun 24, 2024Nationwide• Neilmed Pharmaceuticals Inc

Venlafaxine Extended-Release Capsules (Zydus) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

Class IIModerate

FDAJun 21, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

BioFire Blood Culture Panel (BioFire) – False Positive Concern (2024)

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

FDAJun 19, 2024Nationwide• BioFire Diagnostics, LLC

Venlafaxine Hydrochloride (Major Pharmaceuticals) – Dissolution Failure (2024)

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Class IIModerate

FDAJun 18, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Afinion 2 Analyzer (Abbott) - Complexity Configuration (2024)

Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

FDAJun 17, 2024Nationwide• Abbott Diagnostics Technologies AS Kjelsasveien

Zilretta (Pacira) – Dissolution Specifications (2024)

Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C

Class IIModerate

FDAJun 12, 2024Nationwide• PACIRA PHARMACEUTICALS INC

I-PACK Injection Kit (Synergetics) - Sterilization Validation (2024)

Sterilization certificates could not be validated by the supplier

FDAJun 12, 2024Nationwide• Synergetics Inc

BIOFIRE FILMARRAY Pneumonia Panel (BioFire) - Control Failure (2024)

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

FDAJun 10, 2024Nationwide• BioFire Diagnostics, LLC