Class II U.S. Food and Drug Administration

Sandoz Inc Cyclophosphamide Injection 500 mg/5 mL , Hazardous Drug recall: cGMP deviations: Temperature excursion during transportation

Recall published 1+ years ago

cGMP deviations: Temperature excursion during transportation.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: cGMP deviations: Temperature excursion during transportation.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0651-2025
Published
September 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Sandoz Inc
Product type
Prescription & OTC drugs
Units affected
6 vials
Distribution
Nationwide
Made in
United States
Lot / 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
UPC codes
00307813528104, 10686040629319, 10687281435306, 10687409963168, 10701200331212, 10687325644911, 10687661160169

Products covered by this recall

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.

Check your product

The notice names 19 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00307813528104
  • 10686040629319
  • 10687281435306
  • 10687409963168
  • 10701200331212
  • 10687325644911
  • 10687661160169

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 28
  • 2027

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 02
  • 28
  • 2027

NDC number

On the carton and again on the bottle or blister label.

  • 0781-3528-75
  • 0781-3528-10

Model or item number

On the rating label, the box or the instruction sheet.

  • Vial NDC# 0781-3528-75
  • Carton NDC# 0781

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mg
  • 5 mL
  • 100 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Sandoz Inc — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Sandoz Inc — 100 College Rd W, Princeton, NJ, 08540-6604

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sandoz Inc prescription & otc drugs recalled?

cGMP deviations: Temperature excursion during transportation. cGMP deviations: Temperature excursion during transportation.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00307813528104, 10686040629319, 10687281435306; lot code 28, 2027; best-by date 02 or 28; model number Vial NDC# 0781-3528-75, Carton NDC# 0781. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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