Class III โ€” Low Risk

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

Ketoconazole Shampoo Recalled by Tolmar, Inc. Due to Subpotent

Date: September 23, 2013
Company: Tolmar, 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 Tolmar, Inc. directly.

Affected Products

Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.

Quantity: 391,055 bottles

Why Was This Recalled?

Subpotent

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tolmar, Inc.

Tolmar, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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