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Ongoing FDAEvent 98921 (5 months ago)

Sun Pharmaceutical Doxorubicin Hydrochloride Liposome Injection

DOXOrubin Hydrochloride Liposome injection contains glass particles that may cause irritation, swelling, blood vessel blockage, or life-threatening clots.

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

2 photos

What to do

What happened

If administered intravenously, they may cause local irritation or swelling, and more serious risks include blockage of blood vessels and life-threatening blood clot events. No adverse events have been reported to date.

What to do

If a code on your package matches:

  1. Distributors/retailers/hospitals/users that have the product should stop using.
  2. Return to place of purchase or discard the product.
  3. Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.
  4. Customers with questions regarding this recall can contact Inmar Inc., (Sun Pharma’s recall processor) by 855-745-9357, Monday through Friday between 8:30 am and 5:00 pm, U.S. Eastern Time, or via rxrecalls@inmar.com.

Is yours affected?

Match the NDC, lot code and best-by date listed under your product.

  1. DOXOrubin Hydrochloride Liposome injection

    NDC
    • 72603-200-01
    Lot code
    • HAG2581B
    Best-by
    05/2027

Details

Company began the recall
Sold in

U.S. Nationwide

Event ID
98921
Recall No.
D-0580-2026
Company
SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
Quantity recalled
675 vials
  1. Company began the recall

  2. Announced by the company

  3. Listed on Recall Canary

  4. Added to FDA's Enforcement Report · Classified by FDA

  5. In FDA's weekly enforcement report

  6. Summary updated

All recalls from SUN PHARMACEUTICAL INDUSTRIES INC

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration