Medications & Supplements Critical Severity Voluntary

FDA Posts Eugia Vancomycin Recall Over Glass Particle in Vial

A tiny shard of glass inside an intravenous drug vial can do serious harm to a patient. Eugia US LLC, previously called Auro Medics Pharma LLC, is recalling one lot of its Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL after a glass fragment was spotted in a vial. Facilities holding lot 3VM26026A should pull it from use and set it aside now.

The company announced the action on November 6, 2026, from East Windsor, New Jersey, and the FDA published it on November 9. Eugia is recalling at the hospital, healthcare facility and user level, which makes this chiefly a matter for pharmacies and clinical staff rather than shoppers.

Recalled Products at a Glance

The product is an Eugia-brand single dose vial of vancomycin, 30 mL in size. One lot is involved. To check your stock, look for these markers:

  • Lot 3VM26026A, with an expiration of JUL 2028
  • The product name printed on the carton, which bears NDC 55150-471-10
  • The product name on the vial label, which bears NDC 55150-471-01
  • Packing of 10 vials by 10 printed cartons by 01 shipper, listed under NDC 55150-471-01

Eugia says the whole lot went out to wholesalers across the country between September 2 and September 15, 2026. No unit count appears in the notice.

Advertisement

What Triggered the Recall

Glass turned up inside a vial.

Eugia warns that glass in an injected drug carries a reasonable probability of serious harm. Particles can lodge in blood vessels and form clots that starve major organs of blood. A clot that reaches the lungs, known as a pulmonary embolism, can threaten life, and organ damage may be permanent. Death is among the outcomes the company lists.

Lesser effects named in the notice include irritation at the vein, inflammation, flare-ups of infections already present, and allergic reactions.

Newborns, infants and people whose organs already function poorly may be more vulnerable, the company says. To date, it reports having heard of no adverse events tied to the lot.

Who Should Be Concerned

The recall targets wholesalers, hospitals, pharmacies, institutions and physicians holding the lot. Vancomycin is a glycopeptide antibacterial. Per the notice, it treats septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in adults and in pediatric patients, newborns included.

In general, injectable antibiotics are prepared and given by trained staff, so patients rarely handle vials themselves.

The notice does not list which facilities or states received the lot. It names no retailers and gives no price.

What Consumers Need to Do Now

The steps depend on where you sit in the supply chain.

  • Wholesalers, hospitals, pharmacies, institutions and doctors: stop using lot 3VM26026A and isolate any remaining stock without delay.
  • Passed vials along? Alert every account or site that may have received them.
  • Hospitals and institutions: relay the recall to the clinicians on staff.
  • Returns: Eugia is sending recall letters to distributors and customers and arranging return or replacement of the affected product. Questions about sending it back go to Qualanex at 1-800-505-9291 or recall@qualanex.com, with live calls answered 7:00 am to 4:00 pm M-F CST.
  • Medical questions or adverse event reports: contact Eugia US LLC at 1-866-850-2876 Option 2 or pvg@aurobindousa.com, 8:00 am to 5:00 p.m. (EST) Monday to Friday.
  • Anyone who had a problem that might be linked to the drug should see a physician or healthcare provider.

Reporting a Problem to the FDA

Side effects or quality problems can be sent to the FDA’s MedWatch program. Filing online is possible at www.fda.gov/medwatch/report.htm.

Paper is an option too. Get the form at www.fda.gov/MedWatch/getforms.htm or request one by calling 1-800-332-1088, then mail it to the address printed on the form or fax it to 1-800-FDA-0178.

If a Patient May Have Received the Drug

The notice does not say whether any patient was given a vial from this lot. Patients or family members who are unsure can ask the treating hospital or pharmacy to compare the lot number against its records.

In general, doctors advise prompt medical attention for new chest pain, trouble breathing, or swelling, redness or pain near an injection site after intravenous treatment. A prescribed antibiotic course should not be dropped on a patient’s own initiative. The care team is the right place to decide what happens next.

Frequently Asked Questions

Does the recall cover other vancomycin products or strengths?

The notice names only lot 3VM26026A of the 1.25g/Vial-30mL single dose vial. It identifies no other lots, strengths or products.

Can the public buy this product in stores?

The notice does not say. It frames the recall as reaching the hospital, healthcare facility and user level and mentions no retail sales.

When will replacement vials arrive?

The notice does not specify. Eugia says only that it is arranging return or replacement, and it offers no timing or compensation details.

Does the notice explain how the glass got into the vial?

No. The company describes what was found but gives no cause, no count of affected vials and no details of any testing.

From the Agency

The FDA says it posts company recall announcements as a public service and does not endorse either the product or the company. According to the company notice, Eugia is carrying out the recall with the FDA’s knowledge.