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.

Hydrocortisone Butyrate Lotion 0.1% Recalled by Teligent Pharma, Inc. Due to cGMP deviations: all products within expiry are being...

Date: March 15, 2022
Company: Teligent Pharma, 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 Teligent Pharma, Inc. directly.

Affected Products

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

Quantity: 6431 bottles

Why Was This Recalled?

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teligent Pharma, Inc.

Teligent Pharma, Inc. has 63 total recalls tracked by RecallDetector.

Related Recalls

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