Class III — Low Risk

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

Zoledronic Acid Injection Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Date: September 12, 2018
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

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11

Quantity: 10,530 vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Where Was This Sold?

Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.

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