First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations
First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with documented CGMP deviations. Product intended for quarantine was inadvertently distributed nationwide, representing a quality control failure. Although no illnesses or injuries have been reported, this constitutes a risk-of-harm scenario where manufacturing practice violations allowed substandard product to reach consumers.
Plain-English summary
First Aid Beauty Ltd is recalling First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5% formula, Net Weight 14 oz (396.8 g), Coconut Vanilla variety. The recall affects product distributed nationwide with lot numbers 24D44 (expiration 4/10/2026) and 24D45 (expiration 4/11/2026).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Product that was designated for quarantine was inadvertently distributed to consumers instead of being withheld from distribution. The quarantine designation indicates the product did not meet the manufacturer's quality standards.
Consumers who have purchased this product should discontinue use immediately and discard it or return it to the place of purchase. If you have used this product and have concerns about your health, consult with a healthcare provider.
The recalled product
- 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
- Manufacturer
- First Aid Beauty Ltd
- Category
- Drug — Skincare
- Affected units
- 2,756
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots 24D44
- Exp 4/10/2026 & 24D45
- 4/11/2026
Distribution
Distributed nationwide across the United States.
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