HIGH

Graviti Pharmaceuticals Recalls Bupropion Hydrochloride Tablets Due to Hazard

Graviti Pharmaceuticals recalled 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets on September 15, 2025. The recall stems from failed tablet specifications that could affect safety and efficacy. The product was distributed to pharmacies nationwide.

Quick Facts at a Glance

Recall Date
September 15, 2025
Hazard Level
HIGH
Brands
BUPROPION HYDROCHLORIDE, Rising Pharma Holdings, Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed Tablet/Capsule Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Graviti Pharmaceuticals Private Limited or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recall includes Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, sold in 30-count bottles. The affected batch number is BPB124341A with an expiration date of October 2026.

The Hazard

The recalled tablets failed to meet established specifications, posing a risk to consumers who may rely on them for treatment. The specific nature of the failure has not been detailed.

What to Do

Consumers should stop using the recalled tablets immediately. Contact Graviti Pharmaceuticals or your healthcare provider for guidance on next steps.

Contact Information

For more information, contact Graviti Pharmaceuticals at the provided FDA link or consult your healthcare provider.

Key Facts

  • Recall date: September 15, 2025
  • Distributed to 1 distributor and 16 wholesalers
  • Total quantity recalled: 46,512 bottles
  • Expiration date for affected products: October 2026
  • Risk classification: Class II

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeBupropion Hydrochloride Extended-Release Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Batch # BPB124341A
Exp date: 10/2026
UPC Codes
16571-862
16571-863
16571-862-03
+8 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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