Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Nystatin Oral Suspension Recalled by Pharmaceutical Associates Inc Due to Resuspension problems: Out of specification for appearance and...

Date: May 29, 2018
Company: Pharmaceutical Associates 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 Pharmaceutical Associates Inc directly.

Affected Products

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

Quantity: 275400 cups

Why Was This Recalled?

Resuspension problems: Out of specification for appearance and resuspendability.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pharmaceutical Associates Inc

Pharmaceutical Associates Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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