Class IIReported 2025-10-29

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

Recalled by Graviti Pharmaceuticals Private Limited

Reason for Recall

Failed Tablet/Capsule Specifications

Recall Number

D-0037-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-09-15

Reported

2025-10-29

Distribution

Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.

Code Info

Batch # BPB124341A, Exp date: 10/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.