Class II · Moderate risk Completed
Tizanidine Tablets
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Tizanidine Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
What was recalled
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.
- Recalling firm
- Dr. Reddy'S Laboratories
- NDC code
- 55111-180-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-238-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tizanidine recalls
See all
Class II · Moderate risk Ongoing
Tizanidine Hydrochloride Tablet 4mg
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Tizanidine Tablets
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II · Moderate risk Ongoing
Tizanidine Tablets USP
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk Terminated
Tizanidine HCl Tablets
Reason Failed Tablet/Capsule Specification: Some tablets are shaved
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