Teva Pharmaceuticals USA recalls Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count
Teva Pharmaceuticals USA recalls Dutasteride and Tamsulosin HCl capsules due to failed dissolution tests. All lots within expiry are affected. No remedy specified in recall notice.
Lower-risk recall
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling Dutasteride and Tamsulosin HCl capsules that failed dissolution tests. This means the medication may not work as intended, but the recall does not include a specific action for consumers. Read more at govinfonow.com/recall/41119-teva-dutasteride-and-tamsulosin-capsules-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41119-teva-dutasteride-and-tamsulosin-capsules-recall-failed-dissolution-specifications · Updated October 7, 2026 · FDA enforcement record: FDA #D-0069-2018
Cite this page
“Teva Dutasteride and Tamsulosin Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41119-teva-dutasteride-and-tamsulosin-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0069-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0069-2018%22&limit=1).
Why it’s dangerous
The capsules failed dissolution specifications, meaning they may not release the medication properly in the body. This could lead to the medication not working as intended, but it does not pose a direct physical danger like injury or death.
Who’s affected
People who have the recalled capsules (0.5 mg/0.4 mg) in 30-count or 90-count bottles with specific lot numbers and expiration dates. Men prescribed these medications for prostate issues are most at risk.
How to tell if you have this one
Check for capsules labeled 'Dutasteride and Tamsulosin HCl 0.5 mg/0.4 mg' in 30-count or 90-count bottles with specific lot numbers and expiration dates listed in the recall notice.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Details
Identify the product by checking the bottle's lot number and expiration date against the list provided in the recall notice.
Questions people ask
Why is this product being recalled?
The capsules failed dissolution specifications, meaning they may not release the medication properly in the body.
Do I need to stop using these capsules?
No specific action is required; the recall does not include a remedy for consumers.
What should I do if I have these capsules?
Check the product details to see if it matches the recalled items; no action is needed if it does not match.
Contact Teva Pharmaceuticals USA
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0069-2018 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0069-2018 from Teva Pharmaceuticals USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0069-2018 (October 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0069-2018 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.