The Recall Desk
CriticalFDA (Drugs)·D-0743-2026·Announced 2026-08-12

Cyclophosphamide Injection Recalled Due to Stainless Steel Particulate Matter

Sunny Pharmtech Inc. is recalling 4,077 vials of Cyclophosphamide for Injection due to stainless steel particulate matter found in the product. The recall affects vials distributed nationwide in the USA.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I recall classification applies, which per the rubric qualifies as Critical severity due to reasonable probability of serious adverse health effects from particulate matter in a sterile injectable drug.

Plain-English summary

Sunny Pharmtech Inc. is voluntarily recalling 4,077 vials of Cyclophosphamide for Injection, USP, 1 gram/vial, Rx only. The product is manufactured in Taiwan and distributed nationwide in the USA. The recall is being conducted due to the presence of particulate matter identified as stainless steel in the product.

The affected lots are Lot # C23019V1 with expiration date 10/31/2026, and Lot # C24015V1 with expiration date 4/30/2027. The product is identified by NDC 81298-8112-1 and was manufactured for Long Grove Pharmaceuticals, LLC of Rosemont, Illinois.

Healthcare providers and patients should return the affected vials to their point of purchase or contact their pharmacy for a replacement or refund. The FDA has classified this as a Class I recall, which indicates a reasonable probability of serious adverse health effects. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Manufacturer
Sunny Pharmtech Inc.
Category
Drug — Oncology / Injectable
Hazard
Affected units
4,077

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # C23019V1
  • Exp 10/31/2026
  • C24015V1
  • Exp 4/30/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sunny Pharmtech Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Sunny Pharmtech Inc.

See all →

Same hazard · particulate matter

See all →