FDAClass IRecall started May 12, 2026

DOXOrubin Hydrochloride Liposome injection 50 mg/25mL Recall: Particulate Matter

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC.…

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was DOXOrubin Hydrochloride Liposome injection 50 recalled?

Presence of Particulate matter: Particulate matter identified as glass.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full 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.

Which lot codes, UPCs or models are affected?

Lot HAG2581B, expires: 05/31/2027

Agency record number
D-0580-2026
Product
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC.…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
675 vials
Distribution
U.S. Nationwide
Recall started
May 12, 2026
Report date
June 17, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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