Bupropion Hydrochloride Extended-Release Tablets Recalled Due to Failed Tablet Specifications
Graviti Pharmaceuticals is recalling Bupropion Hydrochloride Extended-Release Tablets (300 mg) due to failed tablet specifications. The recall affects one batch distributed nationwide to pharmacy wholesalers and retailers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall receives a High (3) severity score as a risk-of-harm psychiatric medication with reported specification failures but no documented illnesses or injuries. The FDA Class II classification and the undefined nature of the specification failure on a prescription drug warrant the elevated rating.
Plain-English summary
Graviti Pharmaceuticals Private Limited is recalling Bupropion Hydrochloride Extended-Release Tablets USP, 300 mg (30-count bottles) due to failed tablet specifications. The affected batch is BPB124341A with an expiration date of October 2026.
The product is being recalled because the tablets failed to meet specified manufacturing standards.
The recalled product was distributed nationwide through one pharmaceutical distributor and 16 wholesalers and pharmacy retailers. A total of 46,512 bottles (30-count) are included in the recall.
Patients who have received this medication should contact their healthcare provider or pharmacist. They can verify their batch number against the information provided in this recall. Patients should not stop taking this medication without consulting their healthcare provider or pharmacist.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Category
- Drug
- Hazard
- specification-failure
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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