Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Vancomycin Hydrochloride for Oral Solution Recalled by Amneal Pharmaceuticals of New York, LLC Due to Superpotent Drug: Due to overfilling of drug powder...

Date: March 21, 2024
Company: Amneal Pharmaceuticals of New York, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amneal Pharmaceuticals of New York, LLC directly.

Affected Products

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Quantity: 821 bottles

Why Was This Recalled?

Superpotent Drug: Due to overfilling of drug powder

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amneal Pharmaceuticals of New York, LLC

Amneal Pharmaceuticals of New York, LLC has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report