RecallRadar

FDA Drug recall D-1733-2019

Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube

On 2019-08-21 the FDA classified a Class II recall of Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube by Us Pharmaceuticals, citing CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1733-2019
ClassificationClass II
Statusterminated
Initiated2019-07-11
Published2019-08-21
Last updated2026-09-13 11:52 UTC
CompanyUs Pharmaceuticals
DistributionUS

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 .

Reason

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Identifiers

upc311917182452
ndc0363-0638-01
ndc0363-0638-03
code_infoLot #56J17 EXP 07/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1733-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.