Class II
Ongoing
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.
This recall is currently active, issued October 29, 2025. It was issued by Graviti Pharmaceuticals Private Limited.
- Recall Initiated
- September 15, 2025
- Posted
- October 29, 2025
- Recall Number
- D-0037-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46,512/30 count bottles
- Firm Location
- Hyderabad, India
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Tablet/Capsule Specifications
Distribution
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Lot / Code Info
Batch # BPB124341A, Exp date: 10/2026
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