Ultra Violette
Recalling Firm / Manufacturer: GRACE & FIRE PTY LTD
(Cremorne, Australia)
FDA Recall Number: D-0640-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
Ultra Violette
Generic Name
Not provided by source
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
Not provided by source
Total Quantity Recalled
49,275 tubes
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Full Product Description
Packaging specifications and labeling details
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 17, 2025
Firm Initiation Date
August 22, 2025
FDA Classification Date
Sep 11, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #s: a) 15 mL tubes: A2455, exp 12/31/2026; b) 50 mL tubes: A2453A, A2453B, exp 11/30/2026; A2454A, exp 12/31/2026; A2550, exp 02/28/2027
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Related Questo Medical Knowledge
Clinical cases and condition overviews related to this medication
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0640-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC