Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Neomycin Sulfate Tablets Recalled by X-Gen Pharmaceuticals Inc. Due to Failed Stability Specifications: Out of Specification (OOS) result...

Date: March 19, 2021
Company: X-Gen Pharmaceuticals Inc.
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 X-Gen Pharmaceuticals Inc. directly.

Affected Products

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5

Quantity: 720 100-count (10x10 blister strips)

Why Was This Recalled?

Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About X-Gen Pharmaceuticals Inc.

X-Gen Pharmaceuticals Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

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