Endo Edex 10mcg injection recall: Risk of contamination from defective packaging
Endo Pharmaceuticals recalls Edex 10mcg injections due to potential contamination from defective packaging. This product, sold under Actient, may not be sterile and could cause infections if used.
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Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
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What happened, in plain English
Endo Pharmaceuticals is recalling Edex 10mcg injections because the packaging might not be sterile, which could lead to infections if used. This is a serious issue for people who need this medication for medical reasons. Read more at govinfonow.com/recall/41908-endo-edex-10mcg-injection-recall-risk-of-contamination-from-defective.
Source Summary by GovInfoNow · govinfonow.com/recall/41908-endo-edex-10mcg-injection-recall-risk-of-contamination-from-defective · Updated October 8, 2026 · FDA enforcement record: FDA #D-0512-2017
Cite this page
“Endo Edex 10mcg injection recall: Risk of contamination from defective packaging.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41908-endo-edex-10mcg-injection-recall-risk-of-contamination-from-defective. Based on FDA recall #D-0512-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0512-2017%22&limit=1).
Why it’s dangerous
The packaging may not be sterile, which means the medication could be contaminated with bacteria. If injected, this could cause infections or other health issues.
Who’s affected
People with prescriptions for Edex 10mcg injections, especially those using it for medical conditions like erectile dysfunction. Those who have the specific packaging details listed in the recall are most at risk.
How to tell if you have this one
Check for Edex 10mcg injections in a 2-pack carton, manufactured in Germany, with lot number 207386 and expiration date May 2019. This product was sold under Actient Pharmaceuticals.
- Brand
Endo- Category
Drug
What to do — step by step
Stop using it now
Immediately stop using the recalled Edex 10mcg injections as they may not be sterile and could cause infections.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within 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 16 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.
Questions people ask
What should I do if I have this product?
Stop using it now and contact your healthcare provider for alternative treatment options.
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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-0512-2017 (February 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0512-2017 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.