Tizanidine Tablet
FDA Recall NDC 55111-180
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Tizanidine (NDC 55111-180). A significant event, classified as Class II, was initiated on Jan 02, 2024 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2024 Class II Recall: Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Recall Number
Class II Completed
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Jan 02, 2024
Jan 17, 2024
38,952 bottles
Recall Profile & Regulatory Data
Event ID
93713
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
Batch or Lot Expiration Information
Lot# : T2304007, Exp 7/31/2026
Affected Packages Involved in this Recall
55111-179-30Product
55111-179-15Product
55111-179-03Product
55111-179-10Product
55111-180-30Product
55111-180-15Product
55111-180-03Product
55111-180-10Product
Class II Ongoing
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Jun 21, 2023
Jul 26, 2023
17,548 1000-countbottles
Recall Profile & Regulatory Data
Event ID
92564
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr Reddy's Laboratories Limited
Voluntary / Mandated
N/A
Distribution Pattern
Nationwide in the USA
Product Description
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Batch or Lot Expiration Information
Lot# Lot: T2100585, T2100586, T2100587, Exp 12/2023
Affected Packages Involved in this Recall
55111-179-30Product
55111-179-15Product
55111-179-03Product
55111-179-10Product
55111-180-30Product
55111-180-15Product
55111-180-03Product
55111-180-10Product
Class II Terminated
Failed Tablet/Capsule Specification: Some tablets are shaved
Jul 19, 2021
Aug 25, 2021
37560 bottles
Recall Profile & Regulatory Data
Event ID
88309
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 21, 2022
Product Description
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
Batch or Lot Expiration Information
Lot# : T2000471, exp date 09/2023
Affected Packages Involved in this Recall
55111-179-30Product
55111-179-15Product
55111-179-03Product
55111-179-10Product
55111-180-30Product
55111-180-15Product
55111-180-03Product
55111-180-10Product
Class II Terminated
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Sep 04, 2018
Sep 26, 2018
8376 units
Recall Profile & Regulatory Data
Event ID
80953
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 01, 2022
Product Description
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
Batch or Lot Expiration Information
Lot# : T800304, Exp. 03/2021
Affected Packages Involved in this Recall
55111-179-30Product
55111-179-15Product
55111-179-03Product
55111-179-10Product
55111-180-30Product
55111-180-15Product
55111-180-03Product
55111-180-10Product
3551117915Product
Class III Terminated
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Mar 19, 2013
Apr 10, 2013
117,546 bottles
Recall Profile & Regulatory Data
Event ID
64733
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy'S Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico.
Termination Date
Feb 06, 2014
Product Description
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.
Batch or Lot Expiration Information
Lot# : C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
Affected Packages Involved in this Recall
55111-179-30Product
55111-179-15Product
55111-179-03Product
55111-179-10Product
55111-180-30Product
55111-180-15Product
55111-180-03Product
55111-180-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
