Cyclophosphamide Injection, Solution, Concentrate
FDA Recall NDC 0781-3529
Latest: Class II · Status: Ongoing · Initiated Sep 05, 2025 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cyclophosphamide (NDC 0781-3529). A significant event, classified as Class II, was initiated on Sep 05, 2025 by Sandoz Inc. The reported reason for this action was: "cGMP deviations: Temperature excursion during transportation."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP deviations: Temperature excursion during transportation.
Sep 05, 2025
Sep 24, 2025
6 vials
Recall Profile & Regulatory Data
Event ID
97549
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
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
0781-3528-75Cyclophosphamide
0781-3528-10Cyclophosphamide
0781-3529-70Cyclophosphamide
0781-3529-10Cyclophosphamide
0781-3530-80Cyclophosphamide
0781-3530-10Cyclophosphamide
0030781352Cyclophosphamide
1068604062Cyclophosphamide
1068728143Cyclophosphamide
1068740996Cyclophosphamide
1070120033Cyclophosphamide
1068732564Cyclophosphamide
1068766116Cyclophosphamide
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
