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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 201–220 of 4747 recalls

VITROS Chemistry CRP Slides (Ortho-Clinical) – Labeling Error (2025)

Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

FDAApr 14, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class II

1...9 101112 13...238

Page 11 of 238Next

Moderate

FDAApr 14, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

ClomiPRAMINE Hydrochloride Capsules (Lupin) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

Class IIModerate

FDAApr 10, 2025Nationwide• Lupin Pharmaceuticals Inc.

ChlorproMAZINE Tablets (Zydus) – Impurity Above Limit (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Stratus CS Cardiac Troponin Test (Siemens) – Potential Test Issue (2025)

Laceration Risk

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

FDAMar 31, 2025Nationwide• Siemens Healthcare Diagnostics Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Class IIModerate

FDAMar 26, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Solana Bordetella Complete Assay (Ortho-Clinical) – false positive rate (2025)

It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.

FDAMar 24, 2025IN• Ortho-Clinical Diagnostics, Inc.