Drug FDA Class II Ongoing cGMP deviation

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

First Aid Beauty Ltd Published Jan 29, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact First Aid Beauty Ltd or your place of purchase with questions, and see the source record below for full details.

Reason for recall

CGMP Deviations; product intended for quarantine was inadvertently distributed

Affected products (1)

First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6

2756 jars

Lot codes: 24D44

Code info: Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026

Affected areas

Nationwide

Timeline

Initiated

Dec 23, 2024
Published

Jan 29, 2025

Recall number: D-0206-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.