Zoledronic Acid Injection 5mg/100mL Sterile Solution recall
FDA recall D-0510-2024 · initiated May 23, 2024
Dr. Reddy's Laboratories, Inc. recalled Zoledronic Acid Injection 5mg/100mL Sterile Solution in May 2024 — an FDA Class II recall (D-0510-2024) because Lack of Assurance of Sterility: Leaking vials.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Leaking vials
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,880 vials
Details
- Product
- 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
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 23, 2024
- FDA report date
- Jun 5, 2024
Frequently asked
- Was Zoledronic Acid Injection 5mg/100mL Sterile Solution recalled?
- Dr. Reddy's Laboratories, Inc. recalled Zoledronic Acid Injection 5mg/100mL Sterile Solution in May 2024 — an FDA Class II recall (D-0510-2024) because Lack of Assurance of Sterility: Leaking vials. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Zoledronic Acid Injection 5mg/100mL Sterile Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0510-2024 was: Lack of Assurance of Sterility: Leaking vials
- Is a recalled Zoledronic Acid Injection 5mg/100mL Sterile Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Zoledronic Acid Injection 5mg/100mL Sterile Solution are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: G3000010, Exp. Date 11/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0510-2024.