FDAHealthSeptember 15, 2025
Graviti Pharmaceuticals Private Limited — Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Te
⚠️ Failed Tablet/Capsule Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 15, 2025
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
What's affected?
- 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.
- UPC
- 0316571862030
- Lot code
- Batch # BPB124341A, Exp date: 10/2026
Additional details
Batch # BPB124341A, Exp date: 10/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 46,512/30 count bottles.
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