Agency classClass IIOur severity:High FDA (Drugs)·D-0328-2023·Announced 2023-02-22

Prescription Bupropion Hydrochloride Tablets Recalled for Failed Quality Specifications

Amerisource Health Services LLC is recalling 1,416 cartons of Bupropion Hydrochloride Tablets (75 mg) nationwide due to failed impurities and degradation specifications. The tablets do not meet FDA quality standards for purity.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 Class II drug recall for failed quality specifications (impurities and degradation) with no reported illnesses or injuries. It represents a potential risk of harm from chemical impurities, matching the 'risk-of-harm products where injury has not yet been reported' criterion for Score 3 (High).

Plain-English summary

Amerisource Health Services LLC is recalling 1,416 cartons of Bupropion Hydrochloride Tablets, USP 75 mg nationwide. The product is distributed in 10 x 10 blister packs per carton, with lot number 1003837 and expiration date January 31, 2023. The recall applies to product distributed throughout the United States.

The recall was initiated because the product failed impurities and degradation specifications. The tablets do not meet FDA quality standards for chemical purity and stability.

Consumers who have this medication should consult their healthcare provider or pharmacist about whether to continue using it or obtain a replacement. Patients should not abruptly stop taking Bupropion without medical guidance.

Anyone with questions about this recall can contact their pharmacist or healthcare provider.

The recalled product

Product: BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Brand: BUPROPION HYDROCHLORIDE
Manufacturer: Amerisource Health Services LLC
Category: Drug
Hazard: impurities
product-degradation
Affected units: 1,416

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 #: 1003837
Exp. Date 01/31/2023

Distribution

Distributed nationwide across the United States.

Same brand · BUPROPION HYDROCHLORIDE

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Same manufacturer · Amerisource Health Services LLC

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