Bladder Drug Recalled

Zydus Pharmaceuticals (USA) Inc. is recalling 7248 bottles of oxybutynin chloride extended-release tablets after samples failed to meet dissolution specifications during routine testing, according to the October 11, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects oxybutynin chloride extended-release tablets, 10 mg, in 100-tablet bottles (NDC 68382-256-01) and 500-tablet bottles (NDC 68382-256-05), from lots M300652 and M300651 (Exp. 12/24). The drug was manufactured by Cadila Healthcare Ltd., Ahmedabad, India, and distributed throughout the US by Zydus Pharmaceuticals (USA) Inc., Pennington, New Jersey.

Zydus Pharmaceuticals voluntarily initiated the recall September 21, 2023. On October 4, 2023, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Oxybutynin is a prescription bladder relaxant indicated for the treatment of overactive bladder and for pediatric patients with symptoms of detrusor overactivity associated with a neurological condition such as spina bifida.