Sagent Recalls Zoledronic Acid Injection Due to Sterility Risks
Sagent Pharmaceuticals recalls specific lots of Zoledronic Acid Injection due to lack of sterility assurance and leaking bags. Check lot numbers immediately.
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Lack of Assurance of Sterility; leaking of premix bags
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What happened, in plain English
Sagent Pharmaceuticals Inc has recalled Zoledronic Acid Injection 5 mg per 100 mL single-use bags due to a lack of assurance of sterility and leaking premix bags. The recall affects 10,622 bags distributed nationwide. Specific lot numbers and expiration dates are involved in this Class II recall. Read more at govinfonow.com/recall/46210-sagent-pharmaceuticals-inc-recalls-zoledronic-acid-injection-5-mg-per.
Source Summary by GovInfoNow · govinfonow.com/recall/46210-sagent-pharmaceuticals-inc-recalls-zoledronic-acid-injection-5-mg-per · Updated October 13, 2026 · FDA enforcement record: FDA #D-1615-2014
Cite this page
“Sagent Recalls Zoledronic Acid Injection Due to Sterility Risks.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46210-sagent-pharmaceuticals-inc-recalls-zoledronic-acid-injection-5-mg-per. Based on FDA recall #D-1615-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1615-2014%22&limit=1).
Why it’s dangerous
The primary hazard is a lack of assurance of sterility, which means the medication may not be free from microorganisms. Additionally, leaking bags pose a risk of contamination or incorrect dosing if used. Administering non-sterile intravenous injections can lead to serious infections.
Who’s affected
Patients who have been prescribed or received Zoledronic Acid Injection from Sagent Pharmaceuticals between the manufacturing date and the recall announcement on March 4, 2014. Healthcare providers and pharmacies that distributed these specific lots are also affected.
How to tell if you have this one
Look for Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL) in 100 mL single-use bags packaged in a foil overwrap. Check the NDC number 25021-830-82 and verify if the lot number is 30076 or 30077 with an expiration date of 01/2015.
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Stop Using Affected Lots
Do not use any Zoledronic Acid Injection bags with lot numbers 30076 or 30077 and expiration date 01/2015.
Contact Healthcare Provider
If you have received this medication, contact your healthcare provider for guidance on replacement or alternative treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1615-2014 (March 4, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1615-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.