FDA Announces Amneal Pharmaceuticals’ Nationwide Recall of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml

Amneal said that during the manual bottle-filling stage of manufacturing, some bottles may have been overfilled, which can result in overdosing. The recommended maximum daily dose allowance for the product is up to 2 gm per day, but if the affected product is used in patients who are prescribed that dose, they could receive up to 4 gm per day.

The excess dose may be harmful for patients with renal insufficiency. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest. Some patients with inflammatory disorders of the intestinal mucosa may already have significant systemic absorption of vancomycin and may be at risk for adverse reactions associated with higher doses. To date, Amneal said that it has not received any confirmed reports of adverse events directly related to the recall.

Vancomycin hydrochloride for oral solution USP, 250 mg/5 ml, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile.

The following lots, which were distributed in the United States to wholesalers and distributors from November 9, 2023–February 20, 2024, are affected:

NDC No.	Lot	Expiration Date	Pack Size
69238-2261-3	22613003A	09/2025	80 ml
69238-2261-7	22613004A	09/2025	150 ml
69238-2261-7	22613005A	09/2025	150 ml
69238-2261-5	22613005B	09/2025	300 ml

Amneal said that it is notifying its direct customers via a UPS standard overnight mailed letter and is arranging for the return of the recalled products. It advised customers to immediately examine their existing inventory and quarantine the recalled lots.

Customers who purchased the affected product directly from Amneal may call 833-582-0812, Monday–Friday, 8 am–5 pm EST, or email Vancomycin_Recall@amneal.com for further information.

Retailers who have the recalled product should examine their inventory and cease dispensing any of the affected lots and contact Amneal at Vancomycin_Recall@amneal.com or 833-582-0812, Monday–Friday, 8 am–5 pm EST, for information and instructions to return the product.

Consumers who have vancomycin hydrochloride for oral solution USP, 250 mg/ml, should examine their bottle, cease using the product if the lot number is listed on the recall, and contact Amneal at 833-582-0812, Monday–Friday, 8 am–5 pm EST, or email Vancomycin_Recall@amneal.com for further information and instructions for returning the product. Consumers should also contact their physician and care team if they have experienced any problems that may be related to taking or using this drug product.

Amneal asked consumers to report any adverse reactions or quality problems experienced with the use of this product by contacting Amneal Drug Safety at 877-835-5472, Monday–Friday, 8 am–6 pm EST, or via e-mail at DrugSafety@amneal.com.

FDA asked consumers and healthcare professionals to report any adverse reactions or quality problems experienced with the use of this product to FDA's MedWatch Adverse Event Reporting program.