FDA Drug recall D-0037-2026
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limi…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limi… by Graviti Pharmaceuticals Private, citing failed Tablet/Capsule Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0037-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-15 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Graviti Pharmaceuticals Private |
| Distribution | US |
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
Failed Tablet/Capsule Specifications
Identifiers
| ndc | 16571-862-03 |
|---|---|
| ndc | 16571-862-09 |
| ndc | 16571-862-50 |
| ndc | 16571-862-10 |
| ndc | 16571-862-12 |
| ndc | 16571-863-03 |
| ndc | 16571-863-09 |
| ndc | 16571-863-50 |
| ndc | 16571-863-10 |
| code_info | Batch # BPB124341A, Exp date: 10/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0037-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.