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.

Flucanozole Tablets Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed Dissolution Specifications; 18 month stability time point

Date: December 28, 2016
Company: Dr. Reddy's 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 Dr. Reddy's Laboratories, Inc. directly.

Affected Products

Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

Quantity: a) 42,984 and b) 7,764 bottles

Why Was This Recalled?

Failed Dissolution Specifications; 18 month stability time point

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Dr. Reddy's Laboratories, Inc.

Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.

Related Recalls

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