Unclassified
Nystatin Cream
Failed Stability Specifications
DOXOrubin Hydrochloride Liposome injection (Doxorubicin Hydrochloride)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate matter: Particulate matter identified as glass.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
72603-0200-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Doxorubicin Hydrochloride NDC 72603-0200 |
2 mg/mL | Injectable, Liposomal Intravenous |
NorthStar RxLLC | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 72603-200-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- May 13, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0580-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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All 2026 recalls
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Other particulate / foreign matter recalls from 2026
All particulate / foreign matter recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
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