The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0817-2018·Announced 2018-05-23

Perrigo Recalls Hydrocortisone Ointment for Failed Stability Specifications

Perrigo New York is recalling 571,632 tubes of Hydrocortisone Ointment 2.5% because the product failed stability specifications.

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, which is a moderate risk. The source text does not report any illnesses, injuries, or deaths, and the hazard is a failure of stability specifications rather than a high-risk pathogen or structural defect.

Plain-English summary

Perrigo New York is recalling 571,632 tubes of Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g. The product is a prescription-only topical medication manufactured by Perrigo in Bronx, NY, and distributed by Perrigo in Allegan, MI. The recall is due to the product failing stability specifications.

The affected product is identified by NDC 45802-014-02. Specific lot numbers involved in the recall include 7AT0283V, 7AT0284V, 7AT0285V, 7FT0460, 7FT0461, 7GT0465, 7GT0466, 7JT0390, 7JT0392, 7KT0588, and 7KT0589. These lots have expiration dates ranging from 11/18 to 09/19.

The product was distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
HYDROCORTISONE (HYDROCORTISONE)
Brand
HYDROCORTISONE
Manufacturer
Perrigo New York
Category
Drug — Topical Corticosteroid
Hazard
Affected units
571,632

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 (12)

  • Lot Numbers: 7AT0283V
  • exp. 11/18 7AT0284V
  • exp. 11/18 7AT0285V
  • exp. 11/18 7FT0460
  • exp. 05/19 7FT0461
  • exp. 05/19 7GT0465
  • exp. 06/19 7GT0466
  • exp. 06/19 7JT0390
  • exp. 08/19 7JT0392
  • exp. 08/19 7KT0588
  • exp. 09/19 7KT0589
  • exp. 09/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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