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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

Cyclophosphamide Injection Recalled for Temperature Excursion During Transport

Agency Publication Date: September 15, 2025
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Summary

Sandoz Inc. is recalling 6 specific vials of Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL). This sterile injectable medication, used as a chemotherapy treatment, was exposed to temperatures outside of required limits during transportation. This deviation from Good Manufacturing Practice (GMP) standards can compromise the drug's effectiveness and safety.

Risk

The drug was exposed to improper temperatures during shipping, which could potentially reduce the potency or stability of the medication, leading to less effective treatment for patients.

What You Should Do

  1. Identify if you have the affected product by checking for Lot # 110459 with an expiration date of 02/28/2027.
  2. Check the specific GTN numbers printed on the packaging to see if they match one of the following 6 affected units: (01)00307813528104(21)10686040629319, (01)00307813528104(21)10687281435306, (01)00307813528104(21)10687409963168, (01)00307813528104(21)10701200331212, (01)00307813528104(21)10687325644911, or (01)00307813528104(21)10687661160169.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.

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: Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL)
Variants: 5mL Multiple Dose Vial, Sterile, Rx Only
Serial Numbers:
(01)00307813528104(21)10686040629319
(01)00307813528104(21)10687281435306
(01)00307813528104(21)10687409963168
(01)00307813528104(21)10701200331212
(01)00307813528104(21)10687325644911
(01)00307813528104(21)10687661160169
Lot Numbers:
110459 (Exp 02/28/2027)
NDC:
0781-3528-75
0781-3528-10
GTIN:
00307813528104

Quantity affected: 6 vials. Manufactured in Austria by Fareva Unterach GmbH.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97549
Status: Active
Manufacturer: Sandoz Inc
Sold By: Hospitals; Infusion Centers; Wholesalers
Manufactured In: Austria, India
Units Affected: 6 vials
Distributed To: Nationwide
Agency Last Updated: October 10, 2025

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.