First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First
Summary
The FDA issued a Class II for First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Ne by First Aid Beauty Ltd. Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed.
Details
Source
Drug Recall
External ID
D-0206-2025
Action Date
2025-01-29
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
Quantity Affected: 2756 jars
Reason for Recall
CGMP Deviations; product intended for quarantine was inadvertently distributed
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-23
Company
Newton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (First Aid Beauty Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does First Aid Beauty Ltd have FDA actions?
This is the only FDA action we have on record for First Aid Beauty Ltd in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0206-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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