May 2026 FDA Recall Doxorubicin Hydrochloride by Sun Pharmaceutical Industries Inc
D-0580-2026 - Presence of Particulate matter
This Class I drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on May 12, 2026 for the product Doxorubicin Hydrochloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0580-2026
Presence of Particulate matter: Particulate matter identified as glass.
05-12-2026
06-17-2026
675 vials
Recall Profile & Regulatory Data
Class I - is 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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot HAG2581B, expires: 05/31/2027
