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Class II · ModerateActive recall

Zoledronic Acid

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: G3000010, Exp. Date 11/2025
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: Leaking vials

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameZOLEDRONIC ACID
Generic nameZOLEDRONIC ACID
Active ingredient(s)ZOLEDRONIC ACID
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC55111-688-52
Show the full FDA record
Full product labelZoledronic 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
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide within the United States
Quantity13,880 vials
Recall initiated2024-05-23
Report date2024-06-05
Recall completed—
Recall numberD-0510-2024
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.