thejoe Hydrocortisone Cream

Hydrocortisone Cream recalls: 5 FDA reports

Recalls involving Hydrocortisone Cream. What was wrong with each batch, and how the FDA graded the risk.

5Reports

0Class I

0Ongoing

2019-08-21Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	5

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed B

D-1731-2019 · Class II · reported 2019-08-21 · Terminated

Why it was 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.
Product: 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 went: Distributed Nationwide in the USA
How much: 3114 cases

Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200

D-1733-2019 · Class II · reported 2019-08-21 · Terminated

Why it was 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.
Product: Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-03, UPC 3 11917 18245 2 .
Where it went: Distributed Nationwide in the USA
How much: 305 cases

Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed B

D-1732-2019 · Class II · reported 2019-08-21 · Terminated

Why it was 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.
Product: Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6
Where it went: Distributed Nationwide in the USA
How much: 1223 cases

Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200

D-1734-2019 · Class II · reported 2019-08-21 · Terminated

Why it was 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.
Product: Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6
Where it went: Distributed Nationwide in the USA
How much: 651 cases

Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200

D-0426-2019 · Class II · reported 2019-02-13 · Terminated

Why it was recalled: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Product: 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 went: Nationwide within the United States
How much: 67848 units

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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