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DOXOrubicin Hydrochloride Liposome Injection
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DRUG RECALLCRITICAL

DOXOrubicin Hydrochloride Liposome Injection

Sun Pharma recalls DOXOrubicin Liposome Injection 50 mg/25 mL vials due to glass particulate matter.

What to do

Consumers who have this product should stop using it immediately and contact their healthcare provider for guidance. For further instructions, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555.

Recalled
Listed
Updated
Recall No.
D-0580-2026
Agency
FDA
Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Recall ID
98921
Status
ONGOING

Recall at a glance

Quantity recalled
675 vials

Why it was recalled

Sun Pharmaceutical Industries is recalling DOXOrubicin Hydrochloride Liposome Injection, 50 mg/25 mL (2 mg/mL), 25 mL single-dose vials, due to the presence of glass particulate matter. Administration of a product with particulate matter may cause serious adverse events, including blockage of blood vessels, which can be life-threatening.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Aisling DOXOrubicin Hydrochloride Liposome Injection, 50mg 25 mL

Best-by
05/2027
NDC
72603-200-01
Batch
HAG2581B

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-08-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification