Critical Alert
SUN PHARMACEUTICAL INDUSTRIES INC Recalls DOXOrubin Hydrochloride Liposome injection
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #D-0580-2026Drug / Pharmaceutical
SUN PHARMACEUTICAL INDUSTRIES INC Recalls DOXOrubin Hydrochloride Liposome injection
SUN PHARMACEUTICAL INDUSTRIES INC · Class I — Most Serious
Product Description
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 for Recall
Presence of Particulate matter: Particulate matter identified as glass.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a pharmaceutical product recalled by SUN PHARMACEUTICAL INDUSTRIES INC on May 12, 2026. Presence of Particulate matter: Particulate matter identified as glass. This recall affects 675 vials and was distributed in U.S. Nationwide. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.