Zoledronic Acid Injection — Class II drug recall D-0784-2016
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2016-04-06, distributed nationwide. Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vi
| Recall number | D-0784-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2016-03-03 |
| Classified | 2016-03-28 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 3,342 vials |
| Reason classes | sterility |
| NDC | 55111-0688-52 |
| Lot numbers | BS523 |
| Expiration dates | 2017-10 |
Product
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Reason for recall
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
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-0784-2016. 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.