Overactive Bladder Drug Recalled

Padagis US is recalling more than 7000 bottles of trospium chloride extended-release capsules for failing to meet capsule specifications. According to the December 13, 2023, US Food and Drug Administration (FDA) Enforcement Report, the product contains “missing/broken/extra tablets within the capsules.”

The recall affects trospium chloride extended-release capsules, 60 mg, in 30-capsule bottles (NDC 0574-0118-30) from lots 231104, 231105, and 231106 (Exp. 7/31/25). The product was manufactured by Sidmak Laboratories, Dehradun, Uttarakhand, India, and distributed by Padagis, Allegan, Michigan, throughout the US.

The recall was voluntarily initiated by Padagis US on November 1, 2023. On December 5, 2023, the recall was designated Class II by the FDA. Per the classification, use of the affected capsules could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Trospium chloride extended-release capsules are available with a prescription for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.