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.
Reported: October 29, 2025 Initiated: September 15, 2025 #D-0037-2026
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.
Reason for Recall
Failed Tablet/Capsule Specifications
Details
- Recalling Firm
- Graviti Pharmaceuticals Private Limited
- Units Affected
- 46,512/30 count bottles
- Distribution
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Location
- Hyderabad
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Graviti Pharmaceuticals Private Limited. Units affected: 46,512/30 count bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 29, 2025. Severity: Moderate. Recall number: D-0037-2026.
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