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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