Fresenius Kabi Recalls Midazolam Injection Due to Impurities
Fresenius Kabi USA recalls specific lots of Midazolam Injection USP due to failed impurity specifications. Check lot numbers and expiration dates.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications
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What happened, in plain English
Fresenius Kabi USA, LLC is recalling Midazolam Injection, USP (25 mg/5 mL) because the product failed impurities/degradation specifications. The recall affects specific lots distributed nationwide and in Puerto Rico. No remedy details are currently provided in this record. Read more at govinfonow.com/recall/42121-fresenius-kabi-recalls-midazolam-injection-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/42121-fresenius-kabi-recalls-midazolam-injection-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0456-2017
Cite this page
“Fresenius Kabi Recalls Midazolam Injection Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42121-fresenius-kabi-recalls-midazolam-injection-due-to-impurities. Based on FDA recall #D-0456-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0456-2017%22&limit=1).
Why it’s dangerous
The product failed impurities/degradation specifications, which means the chemical composition may not meet safety standards. This could potentially affect the drug's efficacy or safety profile, though specific injury mechanisms are not detailed in this record.
Who’s affected
Healthcare providers and patients who received Midazolam Injection from the recalled lots. Since it is a prescription drug, the risk is primarily to those administered or prescribed these specific vials.
How to tell if you have this one
Look for Midazolam Injection, USP, *25 mg/5 mL (5 mg/mL), in 5 mL vials sold in cartons of 10. Check for NDC 63323-412-05 and Lot numbers 6007327 or 6007329 with expiration date 01-2017.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Inventory
Verify if you have vials with NDC 63323-412-05 and lots 6007327 or 6007329 expiring in 01-2017.
Contact Provider
If you have these products, contact your healthcare provider or pharmacist for further instructions on what to do with the medication.
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 18 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.
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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-0456-2017 (December 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0456-2017 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.