On January 12, 2024, the U.S. Food and Drug Administration (FDA) reported that Dr. Reddy’s Laboratories Inc. issued a voluntary recall of tizanidine 4 mg tablets.

This recall was initiated as a precautionary measure due to a complaint regarding foreign tablets (2 mg tizanidine tablets) found in a bottle. One lot of the 150-count bottle, distributed in November 2023, was included in this recall. Not included in the recall was Dr. Reddy’s tizanidine 4 mg tablets in a 1,000-count bottle.

The FDA defines a Class II recall as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Since the maximum recommended daily dose of tizanidine is 36 mg, consuming a lower strength tablet (2 mg instead of 4 mg) should not cause serious adverse health consequences.

Impact on workers’ compensation and auto no-fault

Tizanidine is a skeletal muscle relaxant commonly prescribed to claimants for the treatment of muscle spasticity.  Upon review of our transactional data, there was significant utilization of this generic product by the claimants in our book of business.

As a general practice, pharmacies should not dispense recalled products and may contact patients when they receive notification about a recall. Lot numbers may be tracked by the dispensing pharmacy but are not always displayed on the prescription bottle.

If a claimant has questions about this recall and wants to know if this lot number was dispensed to them, they should contact their pharmacy, or contact their prescriber to discuss the use of tizanidine. 

If you have any questions, please contact  your account manager, clinical liaison, or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1. U.S. Food and Drug Administration (FDA) Enforcement Report. January 11, 2024. Available at: https://www.accessdata.fda.gov/scripts/ires/?Event=93713. Accessed on January 12, 2024.
2. U.S. Food and Drug Administration (FDA). FDA’s Role in Drug Recalls. September 29, 2023. Available at: https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls. Accessed on January 16, 2024.
3. California State Board of Pharmacy. Product recall: Dr. Reddy’s Laboratories – Tizanidine HCl Tablets. Available at: https://www.pharmacy.ca.gov/about/recall_alerts/010324_dr_reddys.pdf. Accessed on January 16, 2024.