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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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 →- SevereCyclophosphamide Injection Recall: Stainless Steel Particulate Matter Found
FDA (Drugs) · 2026-08-12
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