Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles
- Date
- May 13, 2026
- Company
- Sun Pharmaceutical Industries, Inc.
- Brand
- Aisling
- Product
- DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
- Reason
- Presence of glass particles
- Hazard
- Other
- Source
- FDA
How to identify the product
- FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials).
- The affected DOXOrubicin Hydrochloride Liposome Injection batch is Batch HAG2581B, Expiration 05/31/2027.
- The product can be identified by the label (Aisling Label), each vial is labeled to indicate the name of the product: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, NDC 72603-200-01 Lot# HAG2581B, Expiration 05/31/2027.
- Sun Pharma is notifying its distributor and customers by express overnight mail and is arranging for return/replacement etc. of all recalled products.
- Distributors/retailers/hospitals/users that have the product should stop using and return to place of purchase or discard the product.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.