FDA Recall D-0651-2025

Sandoz Inc · Princeton, NJ

Class II Ongoing 251 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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 / code: 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

Quantity: 6 vials

Reason for recall

cGMP deviations: Temperature excursion during transportation.

Recall record

Recall number: D-0651-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-09-05
Classified by FDA Center: 2025-09-15
FDA published: 2025-09-24
Recalling firm: Sandoz Inc
Firm location: Princeton, NJ

Drug identification

Brand name(s): CYCLOPHOSPHAMIDE
Generic name(s): CYCLOPHOSPHAMIDE
Manufacturer(s): Sandoz Inc
NDC(s): 0781-3528, 0781-3529, 0781-3530
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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