Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-
Recalled October 11, 2023 · FDA recall D-0038-2024 · Zydus Pharmaceuticals (USA)
Hazard
Failed Dissolution Specifications · FDA Class II
Units
7,248 bottles
Sold at
Nationwide in the USA.
Description
Failed Dissolution Specifications
Product
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →