Drug recall D-0037-2026

Class II Ongoing reported Oct 29, 2025

Product

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

Lots and codes

Batch # BPB124341A, Exp date: 10/2026

Recall details

Recalling firm
Graviti Pharmaceuticals Private Limited, Hyderabad
Quantity
46,512/30 count bottles
Distribution
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Type
Voluntary: Firm initiated
Recall initiated
September 15, 2025

Related products