HIGH

Sandoz Recalls Cyclophosphamide Injection Over Safety Concerns

Sandoz Inc. recalled 263 vials of Cyclophosphamide Injection on September 5, 2025. The recall follows cGMP deviations related to temperature excursions during transportation. Healthcare providers and consumers must stop using the product immediately.

Quick Facts at a Glance

Recall Date
September 5, 2025
Hazard Level
HIGH
Brands
Sandoz, Cyclophosphamide
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

cGMP deviations: Temperature excursion during transportation.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Sandoz Inc or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Cyclophosphamide Injection 500 mg/5 mL, Lot # 110459, with an expiration date of February 28, 2027. It is manufactured in Austria by Fareva Unterach GmbH. The product is distributed nationwide in the USA.

The Hazard

The recall is due to cGMP deviations, specifically temperature excursions that could compromise product integrity. These issues pose a significant risk to patient safety.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The recall is precautionary based on manufacturing deviations.

What to Do

Stop using the recalled product immediately. Contact Sandoz Inc. or your healthcare provider for further guidance.

Contact Information

For more information, contact Sandoz Inc. at their official website or through the recall notification letter.

Key Facts

  • 263 vials recalled
  • Temperature excursion during transportation
  • Lot # 110459, exp. 02/28/2027
  • Nationwide distribution in the USA

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot # 110459 exp. date 02/28/2027
UPC Codes
0781-3528
0781-3529
0781-3530
+6 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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