Class II

Drug Recall: 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

Graviti Pharmaceuticals Private Limited · September 15, 2025

Reason for Recall

Failed Tablet/Capsule Specifications

Product Description

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

46,512/30 count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0037-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.