Muscle Relaxant Recalled

Dr Reddy’s Laboratories is recalling 17,548 bottles of tizanidine tablets because of out-of-specification dissolution results at 24-month stability testing, according to the July 26, 2023, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects tizanidine tablets, 4 mg, in 1000-count bottles (NDC 55111-180-10) from lots T2100585, T2100586, and T2100587 (Exp 12/23). The tablets were manufactured by Dr Reddy’s Laboratories, Srikakulam, India, and were distributed throughout the United States.

Dr Reddy’s Laboratories voluntarily initiated the recall June 21, 2023. The FDA designated it Class II on July 17, 2023. Use of a drug under a Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Tizanidine tablet is a prescription medication indicated for the management of spasticity.