CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Hydrocortisone Ointment recalled by Perrigo New York
Perrigo New York is recalling Hydrocortisone Ointment, USP 2.5%, distributed nationwide in the US. The recall was initiated on 7 May 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0817-2018
- FDA event ID
- 80049
- Recalling firm
- Perrigo New York, Bronx, NY
- Brand
- Hydrocortisone
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2018
- FDA classified
- 16 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 May 2018 | Recall initiated by company | |
| 16 May 2018 | Classified by FDA | +9 days |
| 23 May 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
Where it was distributed
US Nationwide including Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
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
Where was it sold?
US Nationwide including Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perrigo New York
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ciclopirox shampoo recalled by Perrigo New YorkCiclopirox | Perrigo New York | Potency & Assay | Nationwide |
Other Hydrocortisone recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalledRapidol | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |
| Drug | CLASS III | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid | Taro Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone and Acetic Acid Otic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |