Fresenius Kabi Fluphenazine Decanoate Injection Recall: Subpotent Drug Risk
Fresenius Kabi recalls Fluphenazine Decanoate Injection vials with subpotent drug levels. Affected lots expire by July 2017. Contact for remedy details.
Lower-risk recall
Subpotent Drug
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What happened, in plain English
Fresenius Kabi is recalling Fluphenazine Decanoate Injection vials that may contain less active drug than labeled. This could lead to ineffective treatment if used as prescribed. Read more at govinfonow.com/recall/41809-fresenius-kabi-fluphenazine-decanoate-injection-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41809-fresenius-kabi-fluphenazine-decanoate-injection-recall-subpotent-drug-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0647-2017
Cite this page
“Fresenius Kabi Fluphenazine Decanoate Injection Recall: Subpotent Drug Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41809-fresenius-kabi-fluphenazine-decanoate-injection-recall-subpotent-drug-risk. Based on FDA recall #D-0647-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0647-2017%22&limit=1).
Why it’s dangerous
The drug may have lower-than-stated potency, meaning it might not work as intended for mental health treatment. This could result in inadequate symptom control if the medication is not effective.
Who’s affected
Patients prescribed Fluphenazine Decanoate Injection by a doctor. Those using the product without medical supervision are not affected.
How to tell if you have this one
Check for vials labeled 'Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL' with specific lot numbers: 6111141 (exp. 07/17), 6111222 (exp. 08/17), 6112346 (exp. 01/18), or 6112725 (exp. 03/18).
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the vial to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 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-0647-2017 (March 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0647-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.