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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zoledronic Acid Injection Recalled for Sterility Concerns due to Leaking Vials

Agency Publication Date: May 28, 2024
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Summary

Dr. Reddy's Laboratories, Inc. is recalling 13,880 vials of Zoledronic Acid Injection (5mg/100mL) because some vials were found to be leaking. This medication is a sterile injectable solution used to treat certain bone conditions, and a leak in the vial packaging means the manufacturer cannot guarantee the product remains sterile. If an unsterile drug is injected into a patient, it could cause serious or life-threatening infections.

Risk

Leaking vials break the sterile seal required for injectable medications, potentially allowing bacteria or other contaminants to enter the solution. Administering a contaminated or unsterile medication directly into the bloodstream poses a high risk of systemic infection and severe illness.

What You Should Do

  1. This recall involves 100mL single-dose vials of Zoledronic Acid Injection 5mg/100mL Sterile Solution, identified by NDC 55111-688-52, Lot G3000010, and an expiration date of 11/2025.
  2. Stop using the recalled product immediately.
  3. Contact Dr. Reddy's Laboratories, Inc. or your medical distributor to arrange for the return of any unused vials from the affected lot.
  4. If you are a patient and have concerns about a previous dose, contact your healthcare provider or pharmacist.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Zoledronic Acid Injection 5mg/100mL Sterile Solution (100mL Single-Dose vial)by Dr. Reddy's Laboratories Inc.
Variants: 5mg/100mL, Sterile Solution, Single-Dose vial, Rx only
Lot Numbers:
G3000010 (Exp 11/2025)
NDC:
55111-688-52

Recall #: D-0510-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94686
Status: Active
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: hospitals; clinics; medical distributors
Manufactured In: India, United States
Units Affected: 13,880 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.