Cyclophosphamide for Injection Recall Due to Particulate Matter

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Sunny Pharmtech Inc. is recalling 1,464 vials of Cyclophosphamide for Injection, USP due to the presence of stainless steel particulate matter.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 18, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.

What Happened

Sunny Pharmtech Inc. initiated a voluntary recall of Cyclophosphamide for Injection, USP after identifying the presence of particulate matter identified as stainless steel.

Which Products Are Affected

The recall affects Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1. Lot # V24010V1, Exp 3/31/2027. A total of 1,464 vials are affected. The product was distributed USA Nationwide. Recall number D-0744-2026.

What You Should Do

Consumers and healthcare providers should follow guidance from the recalling firm regarding the affected product.

Why This Matters

This Class I recall involves an injectable drug distributed nationwide that may contain stainless steel particles.

Source

FDA recall D-0744-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Sunny Pharmtech Inc. is recalling 1,464 vials of Cyclophosphamide for Injection, USP due to the presence of stainless steel particulate matter.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.