Sagent Recalls Fluconazole Injection Due to Metronidazole Contamination
Sagent Pharmaceuticals recalls specific lots of Fluconazole Injection due to cross-contamination with metronidazole. Check lot numbers and expiration dates.
Stop using this now
Cross contamination with other products: metronidazole
Contact the company
What happened, in plain English
Sagent Pharmaceuticals is recalling Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, single-dose container bags. The recall is necessary because the product may be cross-contaminated with metronidazole, another medication. This affects specific lots distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43134-sagent-recalls-fluconazole-injection-due-to-metronidazole-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/43134-sagent-recalls-fluconazole-injection-due-to-metronidazole-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0780-2016
Cite this page
“Sagent Recalls Fluconazole Injection Due to Metronidazole Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43134-sagent-recalls-fluconazole-injection-due-to-metronidazole-contamination. Based on FDA recall #D-0780-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0780-2016%22&limit=1).
Why it’s dangerous
The presence of metronidazole in a fluconazole injection can lead to unintended drug interactions or adverse effects in patients who do not require metronidazole treatment. This cross-contamination poses a risk of serious injury due to incorrect medication administration.
Who’s affected
Patients who have received or are prescribed Fluconazole Injection from Sagent Pharmaceuticals during the affected distribution period. Healthcare providers and pharmacies holding this specific inventory are also directly affected.
How to tell if you have this one
Look for Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only. Specifically check for NDC 25021-0113-82 and Lot #40608 with an expiration date of 5/17.
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Stop using the product
Do not use any Fluconazole Injection bags matching the recalled lot number or NDC.
Contact healthcare provider
If you have already received this medication, contact your doctor or pharmacist immediately for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months 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.
Questions people ask
What is the NDC number for the recalled items?
The National Drug Code (NDC) is 25021-0113-82.
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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-0780-2016 (March 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0780-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.