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FDA recall announcement

Cyclophosphamide recall 2026

Three lots of cyclophosphamide for injection were voluntarily recalled to the user level because of steel particulate matter.

A specific recall was announced.

Particulate matter identified as steel was found in the product.

FDA publish date
July 24, 2026
Company
Sunny Pharmtech, Inc.
Product
Cyclophosphamide for Injection, USP, 1 g/vial and 2 g/vial
Last checked
September 23, 2026
NDC / identifier
81298-8112-1, 81298-8114-1
Affected lot(s)
C23019V1, C24015V1, V24010V1

What the FDA announcement says

Particulate matter identified as steel was found in the product.

Read the original FDA cyclophosphamide recall announcement →

What to check on the package

  1. Confirm the exact product and brand name.
  2. Compare the manufacturer or distributor.
  3. Match the NDC or product identifier.
  4. Match the lot or code exactly; a drug name alone is not enough.

Listed expiration date(s): October 2026, April 2027, March 2027

What to do

Pharmacies and healthcare facilities should stop use and dispensing, quarantine affected inventory, and follow the recall return instructions.

Do not stop or change a prescribed medication based only on this page. Contact a pharmacist, prescriber, or the recalling company for instructions specific to your product.

Related FDA enforcement records

3 matching records appear in the current 24-month openFDA snapshot. Use the search tool to compare the exact manufacturer, NDC, and lot.

Search all records for Cyclophosphamide →

Source and limitations

This server-rendered page summarizes an FDA source and the openFDA enforcement snapshot last checked on September 23, 2026. It is not an FDA service and does not provide individual medical advice.