Stainless steel particulate in vials of the chemotherapy drug cyclophosphamide — when the manufacturer and the name on the label are different (Sunny Pharmtech)
The U.S. Food and Drug Administration classified cyclophosphamide for injection (2 g per vial) as Class I — its most serious category — for particulate matter identified as stainless steel. The recall is being conducted by Sunny Pharmtech, which manufactured it in Taiwan, while the label reads "Manufactured for Long Grove Pharmaceuticals." The quantity is 1,464 vials, distributed nationwide.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeDrug
- Recalling firmSunny Pharmtech Inc.
- ReasonPresence of Particulate Matter; identified as stainless steel
- DistributionUSA Nationwide
- Recall initiated2026-07-17
Key points
- Recall number D-0744-2026; FDA Class I, the most serious category; status Ongoing.
- The product is cyclophosphamide for injection, 2 g per vial, single-dose, prescription only, NDC 81298-8114-1; 1,464 vials distributed nationwide.
- The reason is particulate matter identified as stainless steel; the record does not state a cause.
- The label reads "Manufactured for Long Grove Pharmaceuticals" and "Manufactured in Taiwan," while the recalling firm is Sunny Pharmtech.
- A 1 g per vial presentation (4,077 vials) is recorded separately as D-0743-2026 — 5,541 vials across the two.
- The 1,408 FDA recall records this site holds as of 2026-09-01 form 500 firm-and-date groups, 185 of which carry more than one record on the same day.
1What metal particulate in an injectable means
An injectable enters a blood vessel or tissue directly, so foreign matter matters even at sizes invisible to the eye. Particulate reaching the bloodstream can lodge in small vessels or provoke inflammation. In this record the particulate is identified as stainless steel.
Identifying the material suggests the route of contamination may lie on the equipment side, but the record does not state a cause, and this site stays within what is recorded.
2The manufacturer and the name on the label differ
The labeling reads "Manufactured for Long Grove Pharmaceuticals" and "Manufactured in Taiwan," while the recall is being conducted by Sunny Pharmtech. In pharmaceuticals it is common for the company holding the label and brand to be separate from the company that actually makes the product.
What a hospital or pharmacy queries stock against is the NDC and the lot number; relying on a company name alone makes it unclear which of the two to search for.
3Two presentations under the same reason
A 1 gram per vial presentation (4,077 vials, D-0743-2026) is recorded under a separate recall number for the same firm and the same reason. Because presentations get separate numbers, counting by number understates the size of the event. Together the two presentations come to 5,541 vials.
4One event recorded as several numbers
Grouping the 1,408 FDA recall records this site holds as of 2026-09-01 by filing firm and report date gives 500 groups, and in 185 of them the same firm filed more than one record on the same day. The largest group carries 45 at once.
A different strength or pack becomes a different recall number, so what is one event on the floor arrives as several lines in the record. Counting records alone makes more events appear to have happened than did. This record is one half of such a pair, its other strength filed under its own number.
Why it matters
In drug recalls the label holder and the manufacturer differ, so searching stock by company name alone leaves gaps; a system that queries by NDC and lot number is the practical requirement. Because presentations receive separate recall numbers, the size of an event has to be assessed across the product family rather than per number. For an agent such as a chemotherapy drug, where securing a substitute bears on treatment planning, a quality problem converts into a supply problem.
FAQ
Why does particulate matter?
Why is the recalling firm different from the name on the label?
Is 1,464 vials the whole event?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0744-2026