CLASS II ONGOING Drug recall · Reported 5 Jun 2024 · FDA Enforcement Report
Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalled
Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials, distributed nationwide in the US. The recall was initiated on 23 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0510-2024
- FDA event ID
- 94686
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Zoledronic Acid
- Manufacturer
- Dr.Reddy's Laboratories Ltd
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2024
- FDA classified
- 28 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 May 2024 | Recall initiated by company | |
| 28 May 2024 | Classified by FDA | +5 days |
| 5 Jun 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Leaking vials
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalled?
Yes. Dr. Reddy's Laboratories recalled Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials on 23 May 2024. The recall is Class II and its status is Ongoing. Recall number D-0510-2024.
Why was it recalled?
Lack of Assurance of Sterility: Leaking vials
Which lots are affected?
Lot #: G3000010, Exp. Date 11/2025
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Zoledronic Acid recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Zoledronic Acid Injection 5 mg/ 05 mg/mL), Solution recalled | Breckenridge Pharmaceutical | Sterility | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5mg/ 05 mg/mL) vial recalledZoledronic Acid | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5 mg/ 05 mg/mL) One Single-Dose recalledZoledronic Acid | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Zoledronic Acid Injection, 5 mg/ 05 mg/mL) Single Use recalledZoledronic Acid | Dr. Reddy's Laboratories | Foreign Material | Nationwide |
| Drug | CLASS II | Zoledronic Acid Injection 5 mg per 05 mg/mL) single-use recalledZoledronic Acid | Sagent Pharmaceuticals | Sterility | Nationwide |