Bupropion extended release tablets recalled after failing tablet specifications
Graviti Pharmaceuticals is recalling 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets USP (XL) 300 mg from one batch for failed tablet specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a specification failure: the record states only that tablet specifications were not met, without describing a health consequence or reporting injury.
Plain-English summary
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, in 30-count bottles, manufactured by Graviti Pharmaceuticals in Telangana, India and distributed by Rising Pharma, are being recalled for failed tablet/capsule specifications.
The recall covers 46,512 bottles from batch BPB124341A, expiring October 2026, carrying NDC 16571-863-03. The product went to one distributor and 16 wholesalers or pharmacy retailers nationwide. The FDA has classified the recall as Class II.
The enforcement record states the specification failure without describing which characteristic failed or a health consequence, and reports no injuries.
Bupropion is a prescription medicine, so patients holding the affected batch should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Category
- Drug — Antidepressant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # BPB124341A
- Exp date: 10/2026
UPCs (2)
- 0316571862030
- 0316571863037
Distribution
Distributed nationwide across the United States.
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