Cyclophosphamide for Injection recall
FDA recall D-0743-2026 · initiated Jul 17, 2026
Sunny Pharmtech Inc. recalled Cyclophosphamide for Injection in Jul 2026 — an FDA Class I recall (D-0743-2026) because Presence of Particulate Matter; identified as stainless steel.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter; identified as stainless steel
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,077 vials
Details
- 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
- Recalling company
- Sunny Pharmtech Inc.
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jul 17, 2026
- FDA report date
- Aug 12, 2026
Frequently asked
- Was Cyclophosphamide for Injection recalled?
- Sunny Pharmtech Inc. recalled Cyclophosphamide for Injection in Jul 2026 — an FDA Class I recall (D-0743-2026) because Presence of Particulate Matter; identified as stainless steel. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Cyclophosphamide for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0743-2026 was: Presence of Particulate Matter; identified as stainless steel
- Is a recalled Cyclophosphamide for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cyclophosphamide for Injection are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0743-2026.