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.

Nystatin Topical Powder Recalled by X-Gen Pharmaceuticals Inc. Due to Presence of Foreign Substance: potential presence of plastic...

Date: May 17, 2017
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

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

Quantity: 9,816 bottles

Why Was This Recalled?

Presence of Foreign Substance: potential presence of plastic particles.

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