Recall D-0037-2026

US Class II Ongoing · initiated 2025-09-15

Recalling firm

Graviti Pharmaceuticals Private Limited

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 for recall

Failed Tablet/Capsule Specifications

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