Breckenridge Pharmaceutical, Inc recalls Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single
Breckenridge Pharmaceutical recalls Zoledronic Acid Injection 5 mg/100 mL due to impurities found in stability testing. This may cause serious injury if used. Contact for return instructions.
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Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
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What happened, in plain English
Breckenridge Pharmaceutical recalls Zoledronic Acid Injection 5 mg/100 mL vials because impurities were found during stability testing. This could cause serious injury if used improperly. Affected patients should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/37366-breckenridge-zoledronic-acid-injection-recall-impurities-risk-serious-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/37366-breckenridge-zoledronic-acid-injection-recall-impurities-risk-serious-injury · Updated October 5, 2026 · FDA enforcement record: FDA #D-1063-2020
Cite this page
“Breckenridge Zoledronic Acid Injection Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37366-breckenridge-zoledronic-acid-injection-recall-impurities-risk-serious-injury. Based on FDA recall #D-1063-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1063-2020%22&limit=1).
Why it’s dangerous
The product failed stability testing for impurities, which could lead to serious injury if used. This is a medication that must be administered by a healthcare professional.
Who’s affected
Patients prescribed Zoledronic Acid Injection 5 mg/100 mL by a doctor. Those using the product without medical supervision are at risk.
How to tell if you have this one
Check for vials labeled 'Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single'. The lot numbers 5553.044E and 5553.044F were distributed by Breckenridge Pharmaceutical, Inc. in 2021.
- Brand
Breckenridge- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled Zoledronic Acid Injection 5 mg/100 mL vials if you have them.
Questions people ask
Is this product safe to use?
No, the product has failed stability testing for impurities and may cause serious injury. Do not use.
How do I know if I have the recalled product?
Check for vials labeled 'Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single' with lot numbers 5553.044E or 5553.044F.
What should I do if I have the recalled product?
Stop using it immediately and contact Breckenridge Pharmaceutical, Inc. for return instructions.
Contact Breckenridge
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-1063-2020 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-1063-2020 from Breckenridge. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1063-2020 (February 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1063-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.