D-0096-2024Class II

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Completed

Report date

2023-11-15

Distribution

Nationwide.

Firm state

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Product description

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

Code / lot info

M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024

Other recalls SPEQ maps to Validation & Qualification

2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc

See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.