Class III โ€” Low Risk

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

Ciclopirox Olamine Cream USP Recalled by G & W Laboratories, Inc. Due to Labeling: Incorrect or Missing Package Insert: product lots...

Date: March 20, 2017
Company: G & W Laboratories, 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 G & W Laboratories, Inc. directly.

Affected Products

Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.

Quantity: 230,700 tubes

Why Was This Recalled?

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About G & W Laboratories, Inc.

G & W Laboratories, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

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