Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications
Sun Pharmaceutical is recalling nationwide certain lots of Bupropion Hydrochloride Extended-Release Tablets 150 mg because tablets from these lots failed to meet dissolution specifications during stability testing, potentially affecting drug effectiveness.
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 an FDA Class II recall without reported illnesses or injuries. The hazard involves compromised drug efficacy where reduced effectiveness poses a risk of harm even though injury has not yet been reported, fitting the criteria for High severity.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling 5,344 bottles of Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg (NDC 47335-737-86) nationwide in the United States.
The recall was initiated because certain lots failed to meet dissolution specifications during stability testing. Dissolution testing measures whether tablets release the active ingredient at the proper rate. When tablets fail this test, the medication may not be absorbed as intended, potentially affecting its effectiveness.
The affected lots are HAC2240A (expiration 05/2023) and HAC3162A (expiration 07/2023). Patients currently taking affected tablets should consult their healthcare provider or pharmacist to determine the appropriate next steps.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- failed-dissolution
- reduced-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 (4)
- Lots: HAC2240A
- Exp 05/2023
- HAC3162A
- Exp 07/2023
UPCs (2)
- 0347335738865
- 0347335737868
Distribution
Distributed nationwide across the United States.
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- ModerateBupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2023-12-13
- ModerateSun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution
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