Zoledronic Acid Injection — Class III drug recall D-0103-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-10-03, distributed nationwide. Failed Impurities/Degradation Specifications: OOS for unknown impurities.
| Recall number | D-0103-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2018-09-12 |
| Classified | 2018-10-26 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 59,468 vials |
| Reason classes | specification failure |
| NDC | 55111-0688-52 |
| Lot numbers | BS633, BS701, BS702, BS703, BS708, BS709, BS711, BS712, BS713, BS714, BS715, BS726, BS727, BS728, BS729, BS730, BS801 |
| Expiration dates | 2018-09, 2018-12, 2019-03, 2019-06, 2019-07, 2020-03 |
Product
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
Reason for recall
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
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-0103-2019. 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.