FDA announces voluntary recall of a single lot of vancomycin hydrochloride for injection because of potentially dangerous particulate contamination.
Eugia US LLC, formerly Auro Medics Pharma LLC, has initiated a voluntary nationwide recall of one lot of Vancomycin Hydrochloride for Injection USP after a glass particle was discovered inside a vial. The company announced the recall on November 6, 2026, and the FDA published the announcement on November 9.
The affected product is a sterile injectable antibiotic used to treat serious bacterial infections, including bloodstream infections, infective endocarditis, bone infections, and certain respiratory and skin infections.
Recalled Product Identification
Product: Vancomycin Hydrochloride for Injection USP, 1.25 g/vial, 30 mL single-dose vial
Manufacturer/Distributor: Eugia US LLC
Lot Number: 3VM26026A
Expiration Date: July 2028
Vial NDC: 55150-471-01
Carton NDC: 55150-471-10
Distribution: Nationwide, September 2–15, 2026
The recall extends to the hospital, healthcare facility, and user levels.
Potentially Serious Patient Safety Risks
According to the company’s FDA-posted announcement, administering an injectable medication containing glass particles could result in serious adverse health consequences.
Potential complications include blockage or clotting of blood vessels, pulmonary embolism, permanent organ damage, and death. Particulate contamination may also cause local vein irritation, inflammation, allergic reactions, or aggravation of existing infections. Neonates, infants, and patients with compromised organ function may be particularly vulnerable.
Eugia reported that it had received no adverse event reports associated with the recalled product as of its November 6 announcement.
Healthcare Facilities Directed to Quarantine Affected Inventory
Hospitals, pharmacies, wholesalers, healthcare institutions, and physicians possessing the affected lot should immediately discontinue its use and quarantine remaining inventory. Organizations that distributed the product to additional locations should notify those recipients. Eugia is arranging the return or replacement of recalled products.
Healthcare facilities should also ensure that relevant clinical personnel are informed of the recall.
For recall and return assistance, contact Qualanex at 1-800-505-9291 or recall@qualanex.com.
Medical inquiries and adverse-event questions may be directed to Eugia at 1-866-850-2876, option 2, or pvg@aurobindousa.com.
Suspected adverse reactions or product quality problems can also be reported through the FDA’s MedWatch reporting program.
MDP Perspective: Particulate Contamination and Sterile Product Quality
The discovery of glass particulate matter in an injectable medication raises important questions about manufacturing controls, container integrity, inspection processes, and the effectiveness of pharmaceutical quality systems.
Glass particles can originate from several potential sources, including vial manufacturing, filling and handling operations, or damage to containers during processing and distribution. The recall announcement does not identify the source of the particle or establish a root cause.
For manufacturers of sterile injectable products, this type of contamination underscores the importance of effective container and closure controls, validated inspection processes, deviation investigations, and appropriate corrective and preventive actions.
It also illustrates why pharmaceutical quality assurance extends beyond product formulation and sterility. A medication can present serious patient safety risks when foreign particulate matter is introduced into a product intended for injection.
The recall is limited to the identified lot, and the company has not reported associated adverse events. Nevertheless, prompt identification, quarantine, and removal of affected inventory are essential to reducing potential patient exposure.
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