Ascend Laboratories LLC recalls Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,
Ascend Laboratories recalls 150-count Tizanidine 4mg tablets (NDC 67877-614-15) manufactured in India with failed dissolution tests. This medication may not work as intended.
Lower-risk recall
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Contact the company & request your remedy
What happened, in plain English
Ascend Laboratories is recalling 150-tablet Tizanidine 4mg prescription medication because it failed dissolution tests. This means the tablets may not release the medication properly in the body, potentially reducing effectiveness. Read more at govinfonow.com/recall/36657-ascend-laboratories-recalls-tizanidine-4mg-tablets-due-to-failed-dissolution.
Source Summary by GovInfoNow · govinfonow.com/recall/36657-ascend-laboratories-recalls-tizanidine-4mg-tablets-due-to-failed-dissolution · Updated October 4, 2026 · FDA enforcement record: FDA #D-0173-2021
Cite this page
“Ascend Laboratories recalls Tizanidine 4mg tablets due to failed dissolution specs.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36657-ascend-laboratories-recalls-tizanidine-4mg-tablets-due-to-failed-dissolution. Based on FDA recall #D-0173-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0173-2021%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they don't dissolve properly in the body. This could lead to inconsistent medication levels and reduced effectiveness. The issue is related to manufacturing quality control, not a safety hazard.
Who’s affected
Prescription patients who received Tizanidine 4mg tablets with NDC 67877-614-15 manufactured by Alkem Laboratories in Mumbai, India. Patients taking this medication for conditions like spasticity are most at risk.
How to tell if you have this one
Check for the product name 'Tizanidine Tablets, USP 4mg, Rx Only', 150 tablets per bottle, with NDC code 67877-614-15. The lot number is 19143017 and expiration date is May 31, 2021.
- Brand
Ascend Laboratories- Category
Drug
What to do — step by step
Check Medication Details
Verify the NDC code 67877-614-15 and lot number 19143017 on the product label.
Questions people ask
Why is this medication being recalled?
The tablets failed dissolution specifications, meaning they may not release medication properly in the body.
Is this dangerous?
This is a low-risk issue related to medication effectiveness, not safety hazards like injury or death.
What should I do if I have this medication?
Check the NDC code and lot number on the label. If you have the recalled product, contact your doctor or pharmacist for guidance.
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-0173-2021 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0173-2021 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-0173-2021 (November 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0173-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.