Amneal Recalls 4 Lots of Vancomycin Because of Overfilling

Amneal Pharmaceuticals is recalling 4 lots of Vancomycin Hydrochloride for oral solution 250 mg/5mL because the bottles may have been overfilled, which can result in patients receiving a higher than recommended dose. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride is administered orally to treat patients with enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Enterocolitis is an inflammatory condition of the small and large intestine. Pseudomembranous colitis is severe inflammation of the inner lining of the large intestine.

The recommended maximum daily dose is up to 2 grams a day. The overfilled vials could result in patients receiving up to 4 grams a day. This could be harmful to patients with renal insufficiency. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

Patients with inflammatory disorders of the intestinal may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution.

To date, Amneal has not received any reports of adverse events related to this recall.

The lots impacted by this recall all have a September 2025 expiration date and include:

• Lot no. 22613003A with NDC 69238-2261-3; 80 mL
• Lot no. 22613004A with NDC 69238-2261-7; 150 mL
• Lot no. 22613005A with NDC 69238-2261-7; 150 mL
• Lot no. 22613005B with NDC 69238-2261-5; 300 mL