Cyclophosphamide for Injection Recall Due to Particulate Matter
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Sunny Pharmtech Inc. recalls 4,077 vials of Cyclophosphamide for Injection, USP due to 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 due to the presence of particulate matter identified as stainless steel in Cyclophosphamide for Injection, USP.
Which Products Are Affected
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, NDC 81298-8112-1. Lot # C23019V1 (Exp 10/31/2026) and C24015V1 (Exp 4/30/2027). 4,077 vials distributed USA Nationwide. Manufactured for Long Grove Pharmaceuticals, LLC by Sunny Pharmtech Inc. in Taiwan.
What You Should Do
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for return or further instructions.
Why This Matters
This is a Class I recall involving a drug product distributed nationwide.
Source
FDA recall number D-0743-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (805 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.