Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Vancomycin Hydrochloride for Oral Solution, USP 250 mg per 5 mL, distributed nationwide in the United States. The affected product is packaged in 80 mL (NDC 69238-2261-3), 150 mL (NDC 69238-2261-7), and 300 mL (NDC 69238-2261-5) bottles, with approximately 821 bottles involved in the recall.

The product was recalled due to overfilling of drug powder during manufacturing, resulting in superpotent product containing a higher concentration of active ingredient than the labeled strength. The affected lot numbers are 22613003A, 22613004A, 22613005A, and 22613005B, all with an expiration date of September 30, 2025.

The FDA classified this as a Class I recall, indicating the highest level of hazard. Patients taking this medication expect dosing based on the labeled concentration of 250 mg per 5 mL; product with higher actual concentration than labeled creates a serious public health hazard.

The recalled product

Product

VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)

Brand

VANCOMYCIN HYDROCHLORIDE

Manufacturer

Amneal Pharmaceuticals of New York, LLC

Category

Drug

Hazard

• superpotency
• overdose-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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