Recalls / Class II
Class IID-0037-2026
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.
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 16571-862, 16571-863
- FDA application
- ANDA211020
- Affected lot / code info
- Batch # BPB124341A, Exp date: 10/2026
Why it was recalled
Failed Tablet/Capsule Specifications
Recalling firm
- Firm
- Graviti Pharmaceuticals Private Limited
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- E & 621 Patancheru Mandal, Isnapur Village Rd; Survey No 621, Hyderabad, N/A, India
Distribution
- Quantity
- 46,512/30 count bottles
- Distribution pattern
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Timeline
- Recall initiated
- 2025-09-15
- FDA classified
- 2025-10-21
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0037-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.