Zoledronic Acid Injection 5 mg/100 mL — Class III drug recall D-1063-2020
Terminated recall by Breckenridge Pharmaceutical, Inc, reported 2020-03-04, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stab
| Recall number | D-1063-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc, Berlin, CT, United States |
| Recall initiated | 2020-02-24 |
| Classified | 2020-03-25 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 900 vials |
| Reason classes | specification failure |
| NDC | 51991-0064-98 |
| Lot numbers | 5553.044E, 5553.044F |
| Expiration dates | 2021-04-30 |
Product
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
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-1063-2020. 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.