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.

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%) Recalled by US Pharmaceuticals Inc. Due to GMP Deviations: Out of specification results for Total...

Date: December 7, 2018
Company: US 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 US Pharmaceuticals Inc. directly.

Affected Products

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22

Quantity: 19752 units

Why Was This Recalled?

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About US Pharmaceuticals Inc.

US Pharmaceuticals Inc. has 22 total recalls tracked by RecallDetector.

Related Recalls

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