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.

Ezetimibe and Simvastatin Tablets 10mg/80 mg Recalled by Dr. Reddy's Laboratories, Inc. Due to Presence of Foreign Substance: Product complaint of black...

Date: January 15, 2019
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

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10

Quantity: 118 bottles

Why Was This Recalled?

Presence of Foreign Substance: Product complaint of black speckles observed on tablets.

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