CLASS II Drug recall · Reported 13 Feb 2019 · FDA Enforcement Report
Hydrocortisone Cream 1% MS Anti itch Cream recalled
US Pharmaceuticals is recalling Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing tubes, distributed nationwide in the US. The recall was initiated on 7 Dec 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-0426-2019
- FDA event ID
- 81784
- Recalling firm
- US Pharmaceuticals, Belleville, NJ
- Manufacturer
- Walgreens
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2018
- FDA classified
- 4 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Dec 2018 | Recall initiated by company | |
| 4 Feb 2019 | Classified by FDA | +59 days |
| 13 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
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 Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Which lots are affected?
Lot #: 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019
Where was it sold?
Nationwide within the United States
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.
Other products in this recall event
2 other products · FDA event 81784This product is part of a recall event; the main page for the event is Soothe & Cool Protect Moisture Guard Skin Protectant recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soothe & Cool Protect Moisture Guard Skin Protectant recalled | US Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Medline Remedy Essential Barrier Skin Protectant Ointment recalled | US Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from US Pharmaceuticals
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CVS Health Hydrating Healing Ointment (Petrolatum 41%) recalled | US Pharmaceuticals | Manufacturing (CGMP) Deviations | RI |
| Drug | CLASS II | Children Glycerin Suppositories Laxative for ages 2 to Package Size recalled | US Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Health Glycerin Suppositories recalled by US Pharmaceuticals | US Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Adult Glycerin Suppositories, Package Size suppositories recalledWalgreens Adult Glycerin | US Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Therapeutic Menthol Gel recalled by US Pharmaceuticals | US Pharmaceuticals | 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 |