McKesson Inflectra (infliximab-dyyb) Recall: Product Intended for Quarantine Distributed
McKesson recalls Inflectra (infliximab-dyyb) 100mg vials due to cGMP deviations where product intended for quarantine was distributed. This affects specific lots and requires immediate action.
Recall notice
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Contact the company
What happened, in plain English
McKesson is recalling Inflectra (infliximab-dyyb) 100mg per vial injections because some product meant for quarantine was accidentally distributed. This could pose a risk if the product is used without proper quality checks. Read more at govinfonow.com/recall/32331-mckesson-inflectra-infliximab-dyyb-recall-product-intended-for-quarantine-distributed.
Source Summary by GovInfoNow · govinfonow.com/recall/32331-mckesson-inflectra-infliximab-dyyb-recall-product-intended-for-quarantine-distributed · Updated August 17, 2026 · FDA enforcement record: FDA #D-0213-2025
Cite this page
“McKesson Inflectra (infliximab-dyyb) Recall: Product Intended for Quarantine Distributed.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32331-mckesson-inflectra-infliximab-dyyb-recall-product-intended-for-quarantine-distributed. Based on FDA recall #D-0213-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2025%22&limit=1).
Why it’s dangerous
The product was intended for quarantine but was distributed due to a cGMP (current good manufacturing practice) deviation. This means the product may not meet quality standards and could be unsafe for use without proper testing.
Who’s affected
Prescription drug users who have Inflectra (infliximab-dyyb) 100mg vials with lot number 04647349 are affected. Healthcare providers and patients using this specific product are most at risk.
How to tell if you have this one
Check for Inflectra (infliximab-dyyb) 100mg vials with lot number 04647349. The product was distributed by McKesson and manufactured by Celltrion, Inc.
- Brand
McKesson- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot number 04647349 on the Inflectra vial packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0213-2025 (January 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0213-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.