Recall: D-0037-2026

Class II - Potentially Harmful

Class IIClassification

2025-09-15Initiated

OngoingStatus

Graviti Pharmaceuticals PrivatFirm

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

Failed Tablet/Capsule Specifications

Distribution

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.