Use caution Drug recall · FDA · Published November 24, 2020

Ascend Recalls Tizanidine 4mg Tablets Due to Dissolution Failure

Ascend Laboratories recalls 1,200 bottles of Tizanidine 4mg tablets due to failed dissolution specifications. Check your lot number and expiration date.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0173-2021Drug Ascend Laboratories ›

Use caution until it’s fixed

Failed Dissolution Specifications; Out of Specification (low) results were obtained.

Take action

Contact the company

Recalling firmAscend Laboratories LLC339 Jefferson Rd Ste 101 · Parsippany, NJ 07054-3707

✎ GovInfoNow plain-language explainer

Ascend Laboratories LLC is recalling one specific lot of Tizanidine Tablets, USP 4mg because the medication did not meet dissolution specifications. The low results mean the drug may not release properly in the body, potentially affecting its effectiveness. This recall involves 1,200 bottles distributed in Michigan. Read more at govinfonow.com/recall/36657-ascend-recalls-tizanidine-4mg-tablets-due-to-dissolution-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/36657-ascend-recalls-tizanidine-4mg-tablets-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0173-2021

Cite this page

“Ascend Recalls Tizanidine 4mg Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36657-ascend-recalls-tizanidine-4mg-tablets-due-to-dissolution-failure. Based on FDA recall #D-0173-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0173-2021%22&limit=1).

Ascend Laboratories LLC voluntarily recalled Tizanidine Tablets, USP 4mg due to failed dissolution specifications, the FDA said on November 24, 2020. The recall affects 1,200 bottles distributed in Michigan.

How to tell if you have it

Brand: Ascend Laboratories
Product: Tizanidine Tablets, USP 4mg
NDC: 67877-614-15
Lot #19143017
Expiration Date: 05/31/2021
Quantity: 150 Tablets per Bottle

The hazard

The FDA reported that out-of-specification low results were obtained for dissolution specifications. The recall is classified as Class II.

Context

GovInfoNow's records show Ascend Laboratories, LLC has 35 other recalls on record since November 2, 2016. Other recent recalls of similar products include Dabigatran Etexilate Capsules (July 16, 2026), Amlodipine/Olmesartan tablets (July 8, 2026), and Dabigatran etexilate capsules (June 30, 2026).

How to tell if you have this one

Check if you have Tizanidine Tablets, USP 4mg, Rx Only, distributed by Ascend Laboratories LLC. Look for NDC 67877-614-15, Lot #19143017, and an expiration date of 05/31/2021.

Brand
Ascend Laboratories
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your bottle matches NDC 67877-614-15, Lot #19143017, and Exp. 05/31/2021.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the recalled lot and how to proceed.

Where it went and when

Where it was distributed

Distributed in Michigan.

FDA distribution: “MI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Nov 24, 2020Firm started the recall
Dec 9, 2020Published in FDA’s Enforcement Report
Dec 22, 2020FDA classified it Class II
Apr 11, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Ascend Laboratories recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36657-ascend-recalls-tizanidine-4mg-tablets-due-to-dissolution-failure">Ascend Recalls Tizanidine 4mg Tablets Due to Dissolution Failure (GovInfoNow)</a>

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 qwen3.6:35b-a3b on October 11, 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.