Inflectra (infliximab-dyyb) recall
FDA recall D-0213-2025 · initiated Jan 17, 2025
McKesson recalled Inflectra (infliximab-dyyb) in Jan 2025 — an FDA Class II recall (D-0213-2025) because cGMP Deviations: Product intended for quarantine was inadvertently distributed.
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.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 192 vials
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 →
Frequently asked
- Was Inflectra (infliximab-dyyb) recalled?
- McKesson recalled Inflectra (infliximab-dyyb) in Jan 2025 — an FDA Class II recall (D-0213-2025) because cGMP Deviations: Product intended for quarantine was inadvertently distributed. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Inflectra (infliximab-dyyb) recalled?
- Per the FDA enforcement record, the reason for recall D-0213-2025 was: cGMP Deviations: Product intended for quarantine was inadvertently distributed.
- Is a recalled Inflectra (infliximab-dyyb) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Inflectra (infliximab-dyyb) are affected?
- Distributed: Nationwide USA. The recall covers these lots — Lot# 04647349, Exp Date 5/31/2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0213-2025.