Zoledronic Acid Injection 5mg/100mL Sterile Solution — Class II drug recall D-0510-2024
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-06-05, distributed nationwide. Lack of Assurance of Sterility: Leaking vials
| Recall number | D-0510-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-05-23 |
| Classified | 2024-05-28 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 13,880 vials |
| Reason classes | sterility, packaging |
| NDC | 55111-0688-52 |
| Lot numbers | G3000010 |
| Expiration dates | 2025-11 |
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
Reason for recall
Lack of Assurance of Sterility: Leaking vials
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0510-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.