Bupropion Hydrochloride Extended-Release Tablets USP — Class II drug recall D-0037-2026
Ongoing recall by Graviti Pharmaceuticals Private Limited, reported 2025-10-29, distributed nationwide. Failed Tablet/Capsule Specifications
| Recall number | D-0037-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Graviti Pharmaceuticals Private Limited, Hyderabad, India |
| Recall initiated | 2025-09-15 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 46,512 |
| NDC | 16571-0862, 16571-0862-03, 16571-0862-09, 16571-0862-10, 16571-0862-12, 16571-0862-50, 16571-0863, 16571-0863-03, 16571-0863-09, 16571-0863-10, 16571-0863-50 |
| Lot numbers | BPB124341A |
| Expiration dates | 2026-10 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0037-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.