Class IIOngoing

Inflectra (infliximab-dyyb) recall

FDA recall D-0213-2025 · initiated Jan 17, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Details

Product: Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
Recalling company: McKesson
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide USA
Initiated: Jan 17, 2025
FDA report date: Feb 5, 2025

This recall is linked to a product we cover: Inflectra →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0213-2025 ↗

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