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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Bupropion Hydrochloride, Rising Pharma Holdings, Inc.
- Product type
- Bupropion Hydrochloride Extended-Release Tablet (XL) 300 mg
- Model numbers
- BPB124341A, Exp date: 10/2026
- UPC codes
- 16571-862, 16571-863, 16571-862-03, 16571-862-09, 16571-862-50, 16571-862-10, 16571-862-12, 16571-863-03 +3 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 15, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Bupropion hydrochloride extended-release tablets are used as antidepressants and for smoking cessation support in certain regimens. The XL formulation provides a longer dosing interval for some patients.
Why This Is Dangerous
A manufacturing defect causing failed tablet specifications can lead to incorrect dosing or variable drug release, potentially impacting treatment effectiveness or safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Patients may experience treatment disruption or require dose adjustments if the product is not dosed as intended. The issue is a quality control problem rather than an immediate physical hazard.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for NDC 16571-863-03.
- Check batch BPB124341A on the bottle or packaging.
- Verify expiration date 10/2026.
- Confirm bottle count is 30 tablets per bottle and total quantity recalled 46,512.
Where to find product info
NDC and batch numbers are printed on the bottle label and packaging. The recall notice links to enforcement reports with details.
What timeline to expect
Recall status is ACTIVE as of the report date; refunds or replacements are not explicitly described in the notice. Follow manufacturer guidance for a回
If the manufacturer is unresponsive
- Contact Graviti Pharmaceuticals Private Limited for guidance.
- If the company is unresponsive, escalate to FDA MedWatch or the appropriate national regulatory body.
How to prevent similar issues
- Always verify NDC, batch, and expiration before using prescription meds.
- Buy Rx meds from licensed pharmacies only.
- Keep a record of recalls and batch information for future reference.
Documentation advice
Keep recall notices, bottle packaging, receipts, and any correspondence with the manufacturer or distributor.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
NDC: 16571-863-03 Batch: BPB124341A Exp: 10/2026 Quantity recalled: 46,512 bottles Package: 30-count bottles, Rx Only Manufactured by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India Distributed by: Rising Pharma Holdings, Inc. Sold to: 1 distributor and 16 wholesalers/pharmacy retailers nationwide Recall date: 2025-09-15 Status: ACTIVE
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Batch BPB124341A
- 1 distributor and 16 wholesalers/pharmacy retailers nationwide
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.