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Drug FDA Class II Ongoing cGMP deviation

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.

Sandoz Inc Published Sep 24, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Sandoz Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP deviations: Temperature excursion during transportation.

Affected products (1)

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.

CYCLOPHOSPHAMIDE · 6 vials

NDC: 0781-3528, 0781-3529, 0781-3530, 0781-3528-75, 0781-3528-10, 0781-3529-70, 0781-3529-10, 0781-3530-80, 0781-3530-10, 0030781352, 1068604062, 1068728143, 1068740996, 1070120033, 1068732564, 1068766116
Lot codes: 110459
Code info: Only the following 6 GTN Numbers for Lot # 110459 exp. date 02/28/2027: (01)00307813528104(21)10686040629319 (01)00307813528104(21)10687281435306 (01)00307813528104(21)10687409963168 (01)00307813528104(21)10701200331212 (01)00307813528104(21)10687325644911 (01)00307813528104(21)10687661160169

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 5, 2025
  2. Published
    Sep 24, 2025
Recall number
D-0651-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.