CLASS III Drug recall · Reported 4 Mar 2020 · FDA Enforcement Report
Zoledronic Acid Injection 5 mg/ (0.05 mg/mL), Solution recalled
Breckenridge Pharmaceutical is recalling Zoledronic Acid Injection 5 mg/ (0.05 mg/mL), Solution for Intravenous Infusion, Sterile, distributed nationwide in the US. The recall was initiated on 24 Feb 2020 and the FDA has classified it as Class III.
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-1063-2020
- FDA event ID
- 85054
- Recalling firm
- Breckenridge Pharmaceutical, Berlin, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Feb 2020
- FDA classified
- 25 Mar 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Feb 2020 | Recall initiated by company | |
| 4 Mar 2020 | Published in enforcement report | +9 days |
| 25 Mar 2020 | Classified by FDA | +21 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Which lots are affected?
Lot # 5553.044E; 5553.044F, Exp. 04/30/2021
Where was it sold?
Nationwide in the U.S.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 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 Breckenridge Pharmaceutical
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
Other Zoledronic Acid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalled | Dr. Reddy's Laboratories | Sterility | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5mg/ (0.05 mg/mL) vial recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) One Single-Dose recalledZoledronic Acid | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) Single Use recalled | Dr. Reddy's Laboratories | Foreign Material | Nationwide |