United StatesBupropion Hydrochloride Extended‑Release Tablets USP (XL), 300 mg, 30‑count bottles, Rx Only (NDC 16571-863-03), batch BPB124341A, exp 10/2026, manufactured by Graviti Pharmaceuticals Private Limited (Sangareddy, Telangana, India) and distributed by Rising Phar, are being recalled. The recall is for failed tablet/capsule specifications; 46,512 30‑count bottles were distributed to one distributor and 16 wholesalers/pharmacy retailers nationwide.
What's being recalled
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.
Recalling firm: Graviti Pharmaceuticals Private Limited, Hyderabad, India.
How to identify it
Batch # BPB124341A, Exp date: 10/2026
The hazard
Failed Tablet/Capsule Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)