Drug & medication recalls Moderate risk

Graviti Pharmaceuticals Private Limited recalls Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmace…

Recall date
September 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0037-2026
FDA classification
Class II
Brand / firm
Graviti Pharmaceuticals Private Limited
Sold / distributed
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.

Why it was recalled

Failed Tablet/Capsule Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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.

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