Aurobindo's Eugia Recalls Vancomycin Injection Lot Over Risk of Blood Clots, Organ Damage
New Delhi: Eugia US LLC, formerly known as Auro Medics Pharma LLC, has announced a voluntary nationwide recall of Vancomycin Hydrochloride for Injection USP 1.25 g/Vial-30 mL (Single Dose Vial) after glass particles were identified inside the vials. According to the company's announcement, the recall was initiated at the hospital, healthcare facility and user levels. The US Food and Drug Administration (FDA) published the recall announcement on November 9, 2026, as part of its public service notifications.
The recall affects lot number 3VM26026A, with an expiry date of July 2028. The product is marketed under the Eugia brand and carries NDC codes 55150-471-01 on the vial and 55150-471-10 on the carton. The affected lot was distributed to wholesalers across the United States between September 2 and September 15, 2026.
The company stated that the presence of glass particulates in injectable products may result in serious adverse health consequences. Administration of the contaminated product could cause vascular obstruction and blood clot formation, potentially restricting blood flow to vital organs. In severe cases, these complications may lead to pulmonary embolism, permanent organ damage or death. Other potential complications include local vein irritation, inflammatory reactions, aggravation of pre-existing infections and allergic reactions. Neonates, infants and patients with compromised organ function may be particularly susceptible to these risks. However, Eugia US LLC stated that it had not received any reports of adverse events associated with the recalled product as of the announcement date.
Vancomycin hydrochloride is a glycopeptide antibacterial agent indicated for treating serious bacterial infections in adult and paediatric patients, including neonates. Its indications include septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
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Eugia US LLC is notifying distributors and customers through recall letters and making arrangements for the return or replacement of the affected products. Wholesalers, hospitals, pharmacies, healthcare institutions and doctors possessing the recalled lot have been instructed to immediately discontinue its use and quarantine the remaining inventory. The company has also advised distributors to notify any additional accounts or locations that may have received the affected product. Hospitals and healthcare institutions have been asked to inform healthcare professionals within their organisations about the recall.
Consumers with medical queries or those wishing to report adverse events can contact Eugia US LLC between 8:00 AM and 5:00 PM (EST), Monday through Friday, at 1-866-850-2876 (Option 2) or via email at pvg@aurobindousa.com. For general queries regarding product returns, customers can contact Qualanex at 1-800-505-9291 or email recall@qualanex.com. Adverse reactions or product quality complaints associated with the use of the drug may also be reported through the FDA’s MedWatch Adverse Event Reporting Program.
