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Drug recall · FDA · Published February 22, 2019

Ascend Laboratories LLC recalls Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd.,

Ascend Laboratories recalls 0.4 mg Tamsulosin capsules (NDC 67877-450-05) manufactured by Alkem Labs in India. The capsules failed dissolution tests during stability testing.

🇺🇸 FDA recall #D-1066-2019DrugAscend Laboratories ›
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Contact the company & request your remedy

Recalling firmAscend Laboratories LLC339 Jefferson Rd Ste 101, N/A · Parsippany, NJ 07054-3707
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Ascend Laboratories is recalling 500-count bottles of 0.4 mg Tamsulosin Hydrochloride Capsules (Rx only) because they failed dissolution testing. This means the medication may not work properly when taken as directed. Read more at govinfonow.com/recall/39157-ascend-laboratories-recalls-tamsulosin-capsules-due-to-dissolution-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/39157-ascend-laboratories-recalls-tamsulosin-capsules-due-to-dissolution-issues · Updated October 5, 2026 · FDA enforcement record: FDA #D-1066-2019

Cite this page

“Ascend Laboratories recalls Tamsulosin capsules due to dissolution issues.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39157-ascend-laboratories-recalls-tamsulosin-capsules-due-to-dissolution-issues. Based on FDA recall #D-1066-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1066-2019%22&limit=1).

Why it’s dangerous

The capsules failed dissolution testing during stability testing, meaning they may not release the medication properly in the body. This could lead to inconsistent blood pressure control if the medication doesn't dissolve correctly.

Who’s affected

People who have a prescription for these capsules and were prescribed them by a doctor. Those with specific medical conditions requiring precise blood pressure control are most at risk.

How to tell if you have this one

Check for 500-count bottles of 0.4 mg Tamsulosin Hydrochloride Capsules (Rx only) with NDC 67877-450-05. The product was manufactured by Alkem Laboratories Ltd. in Mumbai, India and distributed by Ascend Laboratories in Parsippany, New Jersey.

  • Brand
    Ascend Laboratories
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 67877-450-05 on the bottle label to confirm it's the recalled product.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to failed dissolution testing, which may affect how well the medication works. It's not safe to use without checking if it's recalled.

How do I know if I have the recalled product?

Check for 500-count bottles of 0.4 mg Tamsulosin Hydrochloride Capsules with NDC 67877-450-05.

What should I do if I have the recalled product?

The recall doesn't specify a remedy, so contact your doctor or pharmacist for advice.

Take action

Contact Ascend Laboratories

We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.

Subject: Recall D-1066-2019 — Ascend Laboratories Ascend Laboratories

Hello,

I own a Ascend Laboratories that is covered by recall D-1066-2019 from Ascend Laboratories.

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-1066-2019 (February 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1066-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA