Cardinal Health Inc. Recalls

All product recalls associated with Cardinal Health Inc..

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Recall Summary

Total Recalls

32

Past Year

5

Class I (Serious)

6

Most Recent

Aug 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 1–20 of 32 recalls

Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Class IIModerate

FDAAug 5, 2025KS• Cardinal Health Inc.

Xolair Injection (Cardinal Health) - Temperature Exposure (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

RECOMBINATE Antihemophilic Factor (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class II

Moderate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Omalizumab Injection (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Wegovy (Cardinal Health) – Temperature Storage Abuse (2025)

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

Class IIModerate

FDAApr 9, 2025NC, SC, VA• Cardinal Health Inc.

Dry Eye Relief (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Dry Eye Relief (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Eye Irritation Relief (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• Cardinal Health Inc.