Why it was recalled
Failed Tablet/Capsule Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Batch # BPB124341A, Exp date: 10/2026
Where it was sold
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0037-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 15, 2025
- FDA report date
- Oct 29, 2025
- Quantity
- 46,512/30 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Graviti Pharmaceuticals Private Limited
Original FDA data
Every field from FDA enforcement report D-0037-2026, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Ongoing
- Country
- India
- Event ID
- 97629
- Address
- E & 621 Patancheru Mandal
- Address (line 2)
- Isnapur Village Rd; Survey No 621
- Code information
- Batch # BPB124341A, Exp date: 10/2026
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0037-2026
- Classification
- Class II
- Recalling firm
- Graviti Pharmaceuticals Private Limited
- Product quantity
- 46,512/30 count bottles
- Reason for recall
- Failed Tablet/Capsule Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Recall initiation date
- Sep 15, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2025