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.
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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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 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.
No injuries or incidents related to this product have been reported at this time. The recall is classified as Class II, indicating a potential for serious health issues.
Consumers should stop using the recalled tablets immediately. Contact Graviti Pharmaceuticals or your healthcare provider for guidance on next steps.
For more information, contact Graviti Pharmaceuticals at the provided FDA link or consult your healthcare provider.
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