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.

Zoledronic Acid Injection 5mg/100mL Sterile Solution Recalled by Dr. Reddy's Laboratories, Inc. Due to Lack of Assurance of Sterility: Leaking vials

Date: May 23, 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

Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52

Quantity: 13,880 vials

Why Was This Recalled?

Lack of Assurance of Sterility: Leaking vials

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