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Drug FDA Class II Ongoing Contamination / non-sterility

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

Dr. Reddy's Laboratories, Inc. Published Jun 5, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Dr. Reddy's Laboratories, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: Leaking vials

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

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

ZOLEDRONIC ACID · 13,880 vials

NDC: 55111-688, 55111-688-52
Code info: Lot #: G3000010, Exp. Date 11/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    May 23, 2024
  2. Published
    Jun 5, 2024
Recall number
D-0510-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.