DOXOrubin Hydrochloride Liposome injection recall
FDA recall D-0580-2026 · initiated May 12, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled DOXOrubin Hydrochloride Liposome injection in May 2026 — an FDA Class I recall (D-0580-2026) because Presence of Particulate matter: Particulate matter identified as glass.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate matter: Particulate matter identified as glass.
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: 675 vials
Details
- Product
- DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.
- Recalling company
- Sun Pharm Industries
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- May 12, 2026
- FDA report date
- Jun 17, 2026
This recall is linked to a product we cover: Doxorubicin Hydrochloride (Liposomal) →
Frequently asked
- Was DOXOrubin Hydrochloride Liposome injection recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled DOXOrubin Hydrochloride Liposome injection in May 2026 — an FDA Class I recall (D-0580-2026) because Presence of Particulate matter: Particulate matter identified as glass. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was DOXOrubin Hydrochloride Liposome injection recalled?
- Per the FDA enforcement record, the reason for recall D-0580-2026 was: Presence of Particulate matter: Particulate matter identified as glass.
- Is a recalled DOXOrubin Hydrochloride Liposome 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 DOXOrubin Hydrochloride Liposome injection are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot HAG2581B, expires: 05/31/2027. 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-0580-2026.