Doxorubicin Hydrochloride Liposome Injection Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Sun Pharmaceutical Industries Inc. is recalling 675 vials of Doxorubicin Hydrochloride Liposome injection due to the presence of glass particulate matter.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.

What Happened

Sun Pharmaceutical Industries Inc. initiated a voluntary recall of Doxorubicin Hydrochloride Liposome injection after particulate matter identified as glass was found in the product.

Which Products Are Affected

The recall affects DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, NDC 72603-200-01, Lot HAG2581B (expires 05/31/2027). A total of 675 vials were distributed nationwide in the United States.

What You Should Do

Consumers and healthcare providers should not use the affected product and should contact the recalling firm for return or refund instructions.

Why This Matters

Class I recalls indicate a reasonable probability that use of the product could cause serious adverse health consequences or death.

Source

FDA recall number D-0580-2026, report date 2026-06-17.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Sun Pharmaceutical Industries Inc. is recalling 675 vials of Doxorubicin Hydrochloride Liposome injection due to the presence of glass particulate matter.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.