The Recall Desk
ModerateFDA (Drugs)·D-0517-2021·Announced 2021-06-02

Cardinal Health Recalls Dibucaine Topical Anesthetic Due to Temperature Excursions

Cardinal Health Inc. is recalling 701 cartons of Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment due to intermittent temperature excursions during storage.

What this means for you

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 adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Cardinal Health Inc. is recalling 701 cartons of Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment (NDC 0536-1211-95). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product was distributed to Florida, Georgia, and South Carolina between February 23, 2021, and March 10, 2021. 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.

Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product is an over-the-counter (OTC) ointment used for hemorrhoidal conditions.

The recalled product

Product
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL (DIBUCAINE)
Brand
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL
Manufacturer
Cardinal Health Inc.
Category
Drug — Topical Anesthetic
Hazard
Affected units
701

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)

  • All Lots distributed 02/23/2021 through 03/10/2021.

UPCs (1)

  • 0305361211950

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 →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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