Home / Recalls / Graviti Pharmaceuticals Private Limited / D-0037-2026

D-0037-2026 Class II Ongoing

Recalled by Graviti Pharmaceuticals Private Limited — Hyderabad

Recall Details

Product Type: Drugs
Report Date: October 29, 2025
Initiation Date: September 15, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 46,512/30 count bottles

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.

Reason for Recall

Failed Tablet/Capsule Specifications

Distribution Pattern

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

Code Information

Batch # BPB124341A, Exp date: 10/2026