CLASS II ONGOING Drug recall · Reported 29 Jan 2025 · FDA Enforcement Report
Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla recalled
First Aid Beauty is recalling Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, distributed nationwide in the US. The recall was initiated on 23 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0206-2025
- FDA event ID
- 96052
- Recalling firm
- First Aid Beauty, Newton, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Dec 2024
- FDA classified
- 21 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Dec 2024 | Recall initiated by company | |
| 21 Jan 2025 | Classified by FDA | +29 days |
| 29 Jan 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; product intended for quarantine was inadvertently distributed
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations; product intended for quarantine was inadvertently distributed
Which lots are affected?
Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.