FDA Recall D-0206-2025
First Aid Beauty Ltd · Newton, MA
Class II Ongoing 507 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
CGMP Deviations; product intended for quarantine was inadvertently distributed
Recall record
- Recall number
D-0206-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2024-12-23
- Classified by FDA Center
- 2025-01-21
- FDA published
- 2025-01-29
- Recalling firm
- First Aid Beauty Ltd
- Firm location
- Newton, MA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.