CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Hydrocortisone Cream With Aloe recalled by US Pharmaceuticals
US Pharmaceuticals is recalling Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe tube, distributed nationwide in the US. The recall was initiated on 11 Jul 2019 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-1731-2019
- FDA event ID
- 83316
- Recalling firm
- US Pharmaceuticals, Belleville, NJ
- Manufacturer
- Walgreens
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2019
- FDA classified
- 13 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Jul 2019 | Recall initiated by company | |
| 13 Aug 2019 | Classified by FDA | +33 days |
| 21 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
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 With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Which lots are affected?
Lot #63J17 EXP 07/2019, 11P17 EXP 11/2019
Where was it sold?
Distributed Nationwide in the USA
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
17 other products · FDA event 83316This product is part of a recall event; the main page for the event is Cryo-273 Cold Pain Relieving Gel recalled by US Pharmaceuticals.
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 |