Kalchem Vardenafil HCl 500mg Recall: Lack of Stability Data Risk
Kalchem International recalls Vardenafil HCl 500mg (NDC 60592-330-05) due to insufficient stability data affecting expiration dates. Consumers should contact the manufacturer for details.
Lower-risk recall
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Contact the company
What happened, in plain English
Kalchem International is recalling Vardenafil HCl 500mg (NDC 60592-330-05) because the product lacks stability data to support expiration dates. This could lead to ineffective medication if used after the intended expiration. Read more at govinfonow.com/recall/40806-kalchem-vardenafil-hcl-500mg-recall-lack-of-stability-data-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40806-kalchem-vardenafil-hcl-500mg-recall-lack-of-stability-data-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0582-2018
Cite this page
“Kalchem Vardenafil HCl 500mg Recall: Lack of Stability Data Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40806-kalchem-vardenafil-hcl-500mg-recall-lack-of-stability-data-risk. Based on FDA recall #D-0582-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0582-2018%22&limit=1).
Why it’s dangerous
The product was made without sufficient stability data to determine how long it remains effective. This means the expiration date may not be reliable, potentially leading to ineffective medication if used after the intended date.
Who’s affected
Healthcare professionals and researchers who use this product for manufacturing, repackaging, or processing. Those most at risk are individuals handling the product without proper stability testing.
How to tell if you have this one
Check for the product name 'Vardenafil HCl, USP (trihydrate), 500mg', part number 330-05, and NDC 60592-330-05. It was sold for manufacturing and research use only.
- Brand
Kalchem- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Kalchem International at 888-298-9905 for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed in Texas.
FDA distribution: “TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA terminated this recall 2.6 years 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.
Similar recalls
Latest drug recalls
Keep exploring
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-0582-2018 (February 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0582-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.