CLASS II ONGOING Drug recall · Reported 5 Feb 2025 · FDA Enforcement Report
Inflectra (infliximab-dyyb), For injection, 100mg per vial recalled
McKesson is recalling Inflectra (infliximab-dyyb), For injection, 100mg per vial, distributed nationwide in the US. The recall was initiated on 17 Jan 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0213-2025
- FDA event ID
- 96167
- Recalling firm
- McKesson, Irving, TX
- Brand
- Inflectra
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jan 2025
- FDA classified
- 30 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Jan 2025 | Recall initiated by company | |
| 30 Jan 2025 | Classified by FDA | +13 days |
| 5 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Which lots are affected?
Lot# 04647349, Exp Date 5/31/2029
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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