FDA Drugs recall ·
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0580-2026
- Date
- (initiated May 12, 2026)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 675 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Particulate matter: Particulate matter identified as glass.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot HAG2581B, expires: 05/31/2027
Distribution
U.S. Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0580-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.