Ascend Laboratories Tizanidine Tablets Recall: FDA Class II

Why it was recalled

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

Product description

Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.

Lot numbers, UPCs & expiration codes

Lot #19143017, Exp. 05/31/2021

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0173-2021
Classification: Class II
Status: Terminated
Recall initiated: Nov 24, 2020
FDA report date: Dec 9, 2020
Quantity: 1200 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Ascend Laboratories LLC

Original FDA data

Every field from FDA enforcement report D-0173-2021, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 86859
Address: 339 Jefferson Rd Ste 101
Code information: Lot #19143017, Exp. 05/31/2021
Postal code: 07054-3707
Report date: Dec 9, 2020
Product type: Drugs
Recall number: D-0173-2021
Classification: Class II
Recalling firm: Ascend Laboratories LLC
Product quantity: 1200 bottles
Termination date: Apr 11, 2023
Reason for recall: Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Distribution pattern: MI
Recall initiation date: Nov 24, 2020
Initial firm notification: E-Mail
Center classification date: Dec 22, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0173-2021, published Dec 9, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Ascend Laboratories Tizanidine Tablets Recall

Summary