A drug sold in the United States, made in India — the filing firms span 22 countries (Sun Pharmaceutical)
The U.S. FDA classified 675 vials of doxorubicin hydrochloride liposome injection made by Sun Pharmaceutical Industries as Class I — its most serious category — for particulate matter identified as glass. Distribution was U.S. nationwide.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeDrug
- Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
- ReasonPresence of Particulate matter: Particulate matter identified as glass.
- DistributionU.S. Nationwide
- Recall initiated2026-05-12
Key points
- Recall number D-0580-2026; FDA Class I, the most serious category; status Ongoing.
- The product is doxorubicin hydrochloride liposome injection, 50 mg/25 mL, in 25 mL single-dose vials (NDC 72603-200-01).
- The reason is the presence of particulate matter identified as glass.
- Quantity 675 vials, distributed U.S. nationwide; manufactured by Sun Pharmaceutical (India) for Northstar Rx LLC.
- Voluntary, firm-initiated. Initiated 2026-05-12; reported 2026-06-17.
- The firms filing the 1,408 FDA recall records this site holds as of 2026-09-01 sit in 22 countries, with India second at 33 behind the United States at 1,239.
1What particulate in an injectable means
Unlike an oral medicine, an injectable enters the bloodstream directly, bypassing the body's defenses. A particle far too small to see can therefore lead to serious outcomes such as blocking a vessel. The particulate recorded here was identified as glass, pointing to fragments originating in the vial or its production.
This route of administration is why foreign matter in injectables so often lands in Class I, the most serious category.
2The nature of the drug
The product is doxorubicin hydrochloride liposome injection, a medicine used in cancer treatment. "Liposome" refers to a formulation technique that carries the drug inside microscopic lipid vesicles. It is prescription only (Rx only), meaning patients do not buy it themselves; it is administered through a health-care facility.
That difference matters practically: affected units can be traced through hospital and pharmacy inventory, making the recall easier to follow than for an over-the-counter product.
3Manufacturing and distribution across borders
According to the record, the product is manufactured by Sun Pharmaceutical Ind. Ltd. in Halol, Gujarat, India, for Northstar Rx LLC in Memphis, Tennessee. Medicines distributed in the United States are frequently made abroad, so quality control has to hold consistently across borders. That 675 vials went nationwide also shows how prescription drugs disperse widely even in small quantities.
4The filing firms sit in 22 countries
Counting the country of the firm that filed each of the 1,408 FDA recall records this site holds as of 2026-09-01 gives 22 countries. The United States leads with 1,239, followed by India with 33, the Netherlands with 25, Finland with 20 and China with 16.
| Country of the filing firm | Records |
|---|---|
| United States | 1,239 |
| India | 33 |
| Netherlands | 25 |
| Finland | 20 |
| China | 16 |
A recall of a product sold in the United States does not mean the firm filing it is American. A drug manufactured in India and distributed in the United States, as here, is unremarkable, and quality control has to hold consistently across that border.
Why it matters
Foreign matter in injectables can originate outside the formulation — in the container, the stopper, or production equipment — so controlling the drug substance alone does not prevent it. Process control that covers vial handling and the risk of glass breakage, along with the design of visual and automated inspection of finished product, is the central measure. On the hospital side, the ability to query inventory by NDC and lot determines how fast a recall can be handled.
FAQ
Why is particulate in an injectable treated so seriously?
What is a liposome injection?
How are affected units identified?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0580-2026