BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Recall Number: D-0207-2017

Firm: Zydus Pharmaceuticals USA Inc

Classification: Class III

Status: Terminated

Report Date: 20161228

Initiation Date: 20161102

Termination Date: 20200723

Failed Dissolution Specifications; 6 month time point

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534