The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0489-2021·Announced 2021-06-02

Cardinal Health Recalls Bupropion Hydrochloride Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 32 bottles of bupropion hydrochloride tablets due to intermittent exposure to temperature excursions during storage.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (temperature excursion) without reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 32 bottles of bupropion hydrochloride tablets, USP 75 mg. The product is manufactured for Heritage Pharmaceuticals Inc. and is identified by lot number L200791. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific NDC codes for the recalled product are 23155-191-01 and 23155-192-01. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers who have this specific lot of bupropion hydrochloride tablets should stop using them and contact their pharmacist or healthcare provider for a replacement or further instructions. The recall is limited to the 32 bottles associated with lot L200791 distributed in the specified states.

The recalled product

Product
BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Brand
BUPROPION HYDROCHLORIDE
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
32

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 (1)

  • L200791

UPCs (2)

  • 0323155191011
  • 0323155192018

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →

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