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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Inflectra Injection Recalled for Manufacturing Practice Deviations

Agency Publication Date: February 3, 2025
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Summary

McKesson has issued a voluntary recall for 192 vials of Inflectra (infliximab-dyyb) for injection, 100mg per 10 mL single-dose vial. The recall was initiated because the medication was accidentally distributed when it was supposed to remain in quarantine. This error represents a deviation from Current Good Manufacturing Practice (cGMP) standards.

Risk

Products that bypass quarantine and standard quality controls may not meet all safety and potency specifications. There is a risk that the medication may be ineffective or cause unexpected side effects for patients receiving the injection.

What You Should Do

  1. This recall affects Inflectra (infliximab-dyyb) 100mg single-dose vials (NDC 0069-0809-01) with lot number 04647349 and an expiration date of May 31, 2029.
  2. Stop using the recalled product immediately as it is a clinical drug intended for administration by healthcare professionals.
  3. Contact McKesson or your pharmaceutical distributor to arrange for the return of any unused vials from the affected lot.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Inflectra (infliximab-dyyb) (100mg/10 mL vial)
Variants: 100mg per vial, 10 mL single-dose vial, For injection
Lot Numbers:
04647349 (Exp 5/31/2029)
NDC:
0069-0809-01

Recall #: D-0213-2025; Manufactured by Celltrion, Inc. and distributed by Pfizer Labs.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96167
Status: Active
Manufacturer: McKesson
Sold By: McKesson; Pfizer Labs
Manufactured In: United States
Units Affected: 192 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.