Sun Pharmaceutical Industries Inc: Doxorubin Hydrochloride Liposome Injection, 50 Mg/25 Ml (2mg/ml)

Recall Summary Sun Pharmaceutical is recalling DOXOrubin Hydrochloride Liposome injection (a chemotherapy medication) in 50 mg/25 mL vials because glass particles have been found in some batches. The affected product was distributed nationwide across all U.S. states and territories. This is classified as a serious safety issue because the contamination could potentially reach patients receiving the medication.

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC

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.

Reason

Presence of Particulate matter: Particulate matter identified as glass.

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-05-12

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/b2b3b1d0-5e32-42e6-b459-52fa0f22fba3