Graviti recalls bupropion XL 300 mg tablets because they failed tablet specifications
30-count bottles of these extended-release tablets did not meet required tablet specifications, and 46,512 bottles were sent to a distributor and to wholesalers and pharmacies nationwide.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Hazard
- Failed Tablet/Capsule Specifications
- Units
- 46,512/30 count bottles
- Where sold
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 21, 2025
- Recall started
- September 15, 2025
- FDA enforcement report
- October 29, 2025
- Identifiers
- Codes: Batch # BPB124341A, Exp date: 10/2026
- FDA recall number: D-0037-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Reason for recall
- Failed Tablet/Capsule Specifications
- Classification
- Class II (Ongoing)
- Distribution
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Quantity
- 46,512/30 count bottles
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The recall covers 4212 bottles of furosemide tablets (40 mg, 1,000 count) because a foreign substance was found in the product, and the notice does not say what the substance is.
Graviti Pharmaceuticals Private Limited · 4212 bottles