FDA Drugs recall ·
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg… recall
- Recall number
- D-0037-2026
- Date
- (initiated September 15, 2025)
- Company / brand
- Graviti Pharmaceuticals Private Limited
E & 621 Patancheru Mandal, Hyderabad, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 46,512/30 count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Tablet/Capsule Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # BPB124341A, Exp date: 10/2026
Distribution
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0037-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.