FDA recalls Bupropion Hydrochloride tablets for foreign tablet contamination
Rising Pharma Holdings is recalling 47,976 bottles of Bupropion Hydrochloride 150mg tablets nationwide due to foreign tablets or capsules found in some bottles. Consumers should stop use and contact their pharmacist immediately.
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 is a FDA Class II recall for a risk-of-harm product—foreign object contamination of prescription medication—where no illnesses or injuries have been reported. The contamination presents potential for medication errors, qualifying it as High severity per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Rising Pharma Holdings, Inc. is recalling Bupropion Hydrochloride Extended-Release Tablets, USP (XL) 150mg in 30-count bottles due to the presence of foreign tablets or capsules found in some bottles. The affected products were manufactured by Graviti Pharmaceuticals Pvt. Ltd. and distributed nationwide in the United States.
The recall affects approximately 47,976 bottles with lot number BPA123098A and an expiration date of 06/2025. Bupropion is a prescription antidepressant medication used to treat depression and seasonal affective disorder. The presence of foreign tablets or capsules could potentially lead to patients taking unintended medications if the contamination is not detected.
Consumers currently taking the affected medication should stop use and contact their pharmacist or physician immediately. Do not discard the product; return it to the pharmacy where it was dispensed. Consumers with questions about this recall can contact Rising Pharma Holdings, Inc. or speak with their healthcare provider.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug — Antidepressant
- Hazard
- foreign-object-contamination
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)
- Lot #: BPA123098A
- Exp. Date 06/2025
UPCs (2)
- 0316571862030
- 0316571863037
Distribution
Distributed nationwide across the United States.
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