Graviti Pharmaceuticals Private Limited manufactured Bupropion Hydrochloride Extended-Release Tablets XL 300 mg, distributed nationwide by Rising Pharma Holdings, Inc., in 46,512 bottles. The recall cites failed tablet specifications. Stop using the product immediately and contact the manufacturer or your healthcare provider for guidance.
Failed Tablet/Capsule Specifications
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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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.
A manufacturing defect causing failed tablet specifications can lead to incorrect dosing or variable drug release, potentially impacting treatment effectiveness or safety.
This recall is not described as part of a broader industry pattern in the provided information.
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.
NDC and batch numbers are printed on the bottle label and packaging. The recall notice links to enforcement reports with details.
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
Keep recall notices, bottle packaging, receipts, and any correspondence with the manufacturer or distributor.
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
No injuries or incidents have been reported.
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