FDA Recall Tizanidine
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on January 2nd, 2024 and classified as a Class II recall due to presence of foreign tablets/capsules - identified as tizanidine 2 mg tablets. This recall is currently completed, and the associated recall number is recall number is D-0223-2024. It pertains to Tizanidine identified by 55111-179.
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0223-2024 | 01-02-2024 | 01-17-2024 | 38,952 bottles | Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15 | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. | Completed |
| D-0923-2023 | 06-21-2023 | 07-26-2023 | 17,548 1000-countbottles | 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 | Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. | Ongoing |
| D-0750-2021 | 07-19-2021 | 08-25-2021 | 37560 bottles | 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. | Failed Tablet/Capsule Specification: Some tablets are shaved | Terminated |
| D-1191-2018 | 09-04-2018 | 09-26-2018 | 8376 units | 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 | Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . | Terminated |
| D-238-2013 | 03-19-2013 | 04-10-2013 | 117,546 bottles | 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. | Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
