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.

Cinacalcet Tablets Recalled by Dr. Reddy's Laboratories, Inc. Due to CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above...

Date: October 9, 2024
Company: Dr. Reddy's Laboratories, Inc.
Status: Ongoing
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

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

Quantity: 10584 bottles

Why Was This Recalled?

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

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