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Ongoing FDAEvent 99437 (2 months ago)

Long Grove Pharmaceuticals Cyclophosphamide for Injection

Cyclophosphamide for Injection contains stainless steel particulate matter that can cause serious adverse events, including death.

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

What to do

What happened

Sunny Pharmtech Inc., of Taoyuan City, Taiwan, is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, in 1 gram/vial and 2 gram/vial strengths, to the user level due to the presence of particulate matter identified as steel. The recall was initiated July 17, 2026, and announced by the company on July 24, 2026. The products were distributed nationwide in the USA.

The recalled vials are manufactured for Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018, and manufactured in Taiwan. As of the announcement, no adverse events or injuries associated with this particulate matter had been reported.

Summary by Recall Canary from the FDA notice.

What to do

If a code on your package matches:

  1. Consumers with questions regarding this recall may contact Sunny Pharmtech, Inc. at 886-3-4809168, Ext.
  2. Contact your physician or healthcare provider if you have experienced any problem that may be related to taking or using this drug product and do not stop or change prescribed treatment without consulting a healthcare professional.
  3. Pharmacies, hospitals, and other healthcare providers that have the recalled product should immediately stop use and dispensing, and quarantine all affected product inventory, and follow the instructions in the recall notification for arranging return of the affected lots to Cardinal Health.
  4. 7205 or ra@sunnypharmtech.com, Monday through Friday from 9AM to 5PM GMT+8.

Is yours affected?

Match your product and all the details in one listed combination.

  1. Cyclophosphamide for Injection, USP

    1. NDC
      • 81298-8112-1
      Lot code
      • C23019V1
      Best-by
      Oct-2026
      Dosage form / package
      1 g/vial, 50mL vial
    2. NDC
      • 81298-8112-1
      Lot code
      • C24015V1
      Best-by
      Apr-2027
      Dosage form / package
      1 g/vial, 50mL vial
    3. NDC
      • 81298-8114-1
      Lot code
      • V24010V1
      Best-by
      Mar-2027
      Dosage form / package
      2 g/vial, 100 mL vial

Details

Company began the recall
Sold in

USA Nationwide

Event ID
99437
Recall numbers
D-0743-2026 to D-0744-2026
Company
Sunny Pharmtech Inc.Taoyuan City, Taiwan
  1. Company began the recall

  2. Announced by the company · Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. Classified by FDA

  5. In FDA's weekly enforcement report

  6. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration