Graviti Pharmaceuticals Private Limited: Drug Recall

Recall #D-0037-2026 · 09/15/2025

Class II: Risk

Recall Details

Recall Number
D-0037-2026
Classification
Class II
Product Type
Drug
Recalling Firm
Graviti Pharmaceuticals Private Limited
Status
Ongoing
Date Initiated
09/15/2025
Location
Hyderabad, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,512/30 count bottles

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 Pattern

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

Other Recalls by Graviti Pharmaceuticals Private Limited

View all recalls by Graviti Pharmaceuticals Private Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.