FDA recall D-0037-2026

Graviti Pharmaceuticals Private Limited · Class II · drug

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-09-15
Report date
2025-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hyderabad, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0037-2026