Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bupropion Hydrochloride Extended-Release Tablets USP (XL) Recalled by Graviti Pharmaceuticals Private Limited Due to Failed Tablet/Capsule Specifications

Date: September 15, 2025
Company: Graviti Pharmaceuticals Private Limited
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Graviti Pharmaceuticals Private Limited directly.

Affected Products

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.

Quantity: 46,512/30 count bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Graviti Pharmaceuticals Private Limited

Graviti Pharmaceuticals Private Limited has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report