Reported Apr 24, 2024 · Terminated

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b)…

Amneal Pharmaceuticals of New York, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Is this the product you have?

4 of 4 products

Products covered by this recall
#Product as published
1Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3
2(b) 150 mL bottle, NDC 69238-2261-7
3(c)300 mL bottle, NDC 69238-2261-5
4Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Lot codes and dates
    • Lot # (a) 22613003A
    • Exp. date 09/30/2025
    • (b) 22613004A
    • 22613005A
    • Exp. date 09/30/2025
    • (c) 22613005B
    • Exp. date 09/30/2025
Amount recalled
821 bottles

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Superpotent Drug: Due to overfilling of drug powder

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 21, 2025 · Data as of Sep 19, 2:52 PM UTC

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