Why it was recalled
cGMP deviations: Temperature excursion during transportation.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0651-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 5, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- 6 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0651-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97549
- Address
- 100 College Rd W
- Code information
- 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
- Postal code
- 08540-6604
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0651-2025
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 6 vials
- Reason for recall
- cGMP deviations: Temperature excursion during transportation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2025