Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL) Recalled by Breckenridge Pharmaceutical, Inc Due to Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Breckenridge Pharmaceutical, Inc directly.
Affected Products
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.
Quantity: 900 Vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Breckenridge Pharmaceutical, Inc
Breckenridge Pharmaceutical, Inc has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report