Class I U.S. Food and Drug Administration

Aisling DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL recall: Presence of glass particles

Recall published 6 months ago

Presence of glass particles

Aisling Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — glass

This is a foreign-material recall — glass where there should be none. An affected pack looks identical to a sound one from the outside.

What the notice says: If glass particles are administered intravenously, they may pose a risk to patient safety including local irritation or swelling in response to the foreign material.

Why it matters: Pieces of glass may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: glass is usually visible on an X-ray, and a swallowed shard is one of the cases where imaging is worth doing.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0580-2026, D-0598-2026, D-0599-2026
Published
May 13, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Aisling
Product type
Prescription & OTC drugs
Units affected
675 vials
Distribution
Nationwide
Lot / code info
Lot HAG2581B, expires: 05/31/2027 — Lot #: AD93852, Exp Date: 06/2027. — Lot #: AE11393, Exp Date: 10/2027.

Products covered by this recall

DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL

What the company announced

FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials is being recalled due to the detection of glass particles in some vials during production.

If glass particles are administered intravenously, they may pose a risk to patient safety including local irritation or swelling in response to the foreign material. More serious potential risks could include blockage of blood vessels and life-threatening blood clot events. To date, Sun Pharma has not received any reports of adverse events related to this batch. Sun Pharma has thoroughly investigated the source of the problem and has taken corrective and preventative actions.

Doxorubicin Hydrochloride Liposome Injection is indicated for Ovarian cancer, AIDS Related Kaposi Sarcoma and Multiple Myeloma. The product is packaged in translucent, red liposomal dispersion in 25 mL glass, single-dose vials for NDC 72603-200-01. The affected DOXOrubicin Hydrochloride Liposome Injection batch is Batch HAG2581B, Expiration 05/31/2027. The product can be identified by the label (Aisling Label), each vial is labeled to indicate the name of the product: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, NDC 72603-200-01 Lot# HAG2581B, Expiration 05/31/2027.

Sun Pharma is notifying its distributor and customers by express overnight mail and is arranging for return/replacement etc. of all recalled products.

Distributors/retailers/hospitals/users that have the product should stop using and return to place of purchase or discard the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. To report suspected adverse events contact NorthStar Rx LLC at 1-800-206-7821

Customers with questions regarding this recall can contact Inmar Inc. , (Sun Pharma’s recall processor) by 855-745-9357, Monday through Friday between 8:30 am and 5:00 pm, U.S. Eastern Time, or via [email protected] .

Inmar, Inc.

3845 Grand Lakes Way

Grand Prairie, TX 75050

Tel. 855-745-9357

Fax. 817-868-5362

Email: [email protected]

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm 1

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 17 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • HAG2581B
  • AD93852
  • AE11393

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 05/2027
  • 05/31/2027
  • 05
  • 31
  • 2027
  • 06
  • 10

NDC number

On the carton and again on the bottle or blister label.

  • 72603-200-01
  • 72245-762-10
  • 72245-058-10

Package size

Match the net weight or the piece count on the front of the pack.

  • 50 mg
  • 25 mL
  • 2 mg
  • 3 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Glass pieces

Aisling — This is a foreign-material recall — glass where there should be none. An affected pack looks identical to a sound one from the outside.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  3. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  4. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Sun Pharma is notifying its distributor and customers by express overnight mail and is arranging for return/replacement etc. of all recalled products.

Company contact: Sun Pharmaceutical Industries, Inc. — Consumers: Inmar Inc., 855-745-9357, [email protected] — Media: Robert Perry, 1-609-921-4269, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Aisling prescription & otc drugs recalled?

Presence of glass particles If glass particles are administered intravenously, they may pose a risk to patient safety including local irritation or swelling in response to the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code HAG2581B, AD93852, AE11393; best-by date 05/2027 or 05/31/2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

The notice says: Sun Pharma is notifying its distributor and customers by express overnight mail and is arranging for return/replacement etc. of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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