Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurities
Fresenius Kabi USA recalls one lot of Haloperidol Decanoate Injection due to failed impurity specifications. Check your vial details.
Recall notice
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Contact the company
What happened, in plain English
Fresenius Kabi USA is recalling a single lot of Haloperidol Decanoate Injection, 50 mg/mL in 1 mL vials, because the product contained an impurity that did not meet specification standards. The recall covers 48,210 units distributed nationwide and in Puerto Rico. No specific health effects or remedies are listed in this record. Read more at govinfonow.com/recall/43011-fresenius-kabi-recalls-haloperidol-decanoate-injection-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/43011-fresenius-kabi-recalls-haloperidol-decanoate-injection-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0818-2016
Cite this page
“Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43011-fresenius-kabi-recalls-haloperidol-decanoate-injection-due-to-impurities. Based on FDA recall #D-0818-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0818-2016%22&limit=1).
Why it’s dangerous
The product failed impurity specifications, meaning it contained an out-of-specification result for impurities. The record does not describe what those impurities are or how they might affect patient health.
Who’s affected
Patients prescribed Haloperidol Decanoate Injection who received the specific lot identified below. Healthcare providers administering this medication may also be affected.
How to tell if you have this one
Check if you have Haloperidol Decanoate Injection, 50 mg/mL, in a 1 mL vial. Look for NDC 63323-469-01 and Lot # 6111080 with an expiration date of 01/2017.
- Brand
Fresenius Kabi- Category
Drug
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 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0818-2016 (April 7, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0818-2016 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.