Bupropion Extended-Release Tablets Recalled for Dissolution Failure
Amerisource Health Services is recalling Bupropion Hydrochloride 150mg extended-release tablets nationwide due to dissolution specification failures. The tablets dissolve faster than specified limits.
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: FDA Class II recall with a manufacturing defect affecting drug dissolution and absorption. No illnesses or injuries have been reported, but this represents a risk-of-harm product where efficacy may be compromised.
Plain-English summary
Amerisource Health Services LLC is recalling Bupropion Hydrochloride Extended-release Tablets USP (XL) 150 mg due to a manufacturing defect. The recall covers Lot 1017343, expiration date December 31, 2025, with approximately 2,484 cartons affected and nationwide distribution in the United States.
The product failed dissolution specifications. The tablets dissolve faster than the specified limits, which means they break down more quickly than intended during use.
Patients taking this recalled product should contact their healthcare provider or pharmacist immediately for guidance on their treatment. The medication should not be used. Patients should dispose of the product according to FDA guidance for safe medication disposal.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Extended-Release Tablet
- Hazard
- dissolution-failure
- drug-efficacy
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 1017343
- Exp. 12/31/2025
Distribution
Distributed nationwide across the United States.
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