FDAFDA · Food and drugs·Recall number D-0037-2026
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.
Published October 29, 2025 · Recall initiated: September 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Distributor
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- UPC
- 0316571862030
- Lot
- Batch # BPB124341A, Exp date: 10/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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