September 2025 FDA Recall Cyclophosphamide by Sandoz Inc
D-0651-2025 - cGMP deviations

This Class II drug recall was voluntarily initiated by Sandoz Inc on September 5, 2025 for the product Cyclophosphamide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0651-2025

Reason for Recall
cGMP deviations: Temperature excursion during transportation.
Initiated
09-05-2025
Reported
09-24-2025
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97549
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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 Packages Involved in this Recall

0781-3528-75 Cyclophosphamide
0781-3528-10 Cyclophosphamide
0781-3529-70 Cyclophosphamide
0781-3529-10 Cyclophosphamide
0781-3530-80 Cyclophosphamide
0781-3530-10 Cyclophosphamide