Recalling firm
Graviti Pharmaceuticals Private Limited
Product type
Drug
Status
Ongoing
Report date
2025-10-29
Distribution
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Product quantity
46,512/30 count bottles
Initiated by
Voluntary: Firm initiated
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.
Code / lot info
Batch # BPB124341A, Exp date: 10/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.