Bupropion Hydrochloride Recall: Graviti XR 300 mg
FDA is recalling Graviti Pharmaceuticals' Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count Rx bottles. The recall is Batch BPB124341A with expiration 10/2026, and about 46,512 bottles were distributed nationwide to one distributor and 16 wholesalers/pharmacy retailers. The reason for the recall is failed tablet/capsule specifications; corrective action is not provided.
| Brand | Graviti Pharmaceuticals Private Limited |
|---|---|
| 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 |
| Severity | moderate |
| Units affected | 4212 |
| Distribution | Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check your bottles for batch BPB124341A and expiration date 10/2026.
- If affected, stop using the product and contact your healthcare provider or pharmacist for guidance.
- Follow recall instructions from the FDA, the distributor, or the manufacturer to return or dispose of the product.
How to identify the recalled item
| Lot / date codes | Batch # BPB124341A, Exp date: 10/2026 |
|---|---|
| Lot / date codes | Lot# FUB125042G; Exp. 05/13/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.