AuroMedics Fluphenazine Injection Recall: Discoloration Risk
AuroMedics Pharma recalls Fluphenazine Decanoate Injection vials with discoloration or hazy solution. This may affect patients using injectable medication for mental health conditions.
Lower-risk recall
Discoloration; Hazy solution found in one vial instead of a clear solution.
Contact the company
What happened, in plain English
AuroMedics Pharma is recalling Fluphenazine Decanoate Injection vials that may have discoloration or a hazy solution. This could affect patients using the medication for mental health conditions, as the appearance may indicate instability. Read more at govinfonow.com/recall/37708-auromedics-fluphenazine-injection-recall-discoloration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37708-auromedics-fluphenazine-injection-recall-discoloration-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0609-2020
Cite this page
“AuroMedics Fluphenazine Injection Recall: Discoloration Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37708-auromedics-fluphenazine-injection-recall-discoloration-risk. Based on FDA recall #D-0609-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0609-2020%22&limit=1).
Why it’s dangerous
The vial may show discoloration or a hazy solution instead of being clear. This indicates the medication might be unstable, potentially affecting its effectiveness or safety.
Who’s affected
Patients prescribed Flup:enazine Decanoate Injection by a healthcare provider. Those using the medication for mental health conditions are most at risk if they have the recalled vial.
How to tell if you have this one
Check for discoloration or hazy solution in the vial. The product was manufactured in India by AuroMedics Pharma LLC and sold with lot number CFD190004, expiring August 2020.
- Brand
AuroMedics- Category
Drug
What to do — step by step
Check Vial Appearance
Look for discoloration or hazy solution instead of a clear solution.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 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-0609-2020 (November 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0609-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.