The Recall Desk
ModerateFDA (Drugs)·D-0487-2021·Announced 2021-06-02

Cardinal Health Recalls Hydrocortisone Ointment Due to Temperature Excursions

Cardinal Health Inc. is recalling 23 tubes of Hydrocortisone Ointment USP 1% due to intermittent exposure to 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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is a storage condition deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 23 tubes of Hydrocortisone Ointment USP 1% Maximum Strength, Net Wt. 1 oz (28 g), NDC 0472-0345-56. The product was manufactured by Actavis Mid Atlantic LLC in Lincolnton, NC.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected lots were distributed between February 23, 2021, and March 10, 2021.

The product was distributed in Florida, Georgia, and South Carolina. Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902
Manufacturer
Cardinal Health Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
23

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

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.

See all →

Same hazard · temperature excursion

See all →