suntegrity — Class I drug recall D-0588-2024
Ongoing recall by SYNCHRONICITY SPA INC, DBA SUNTE, reported 2024-07-17, distributed nationwide. Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
| Recall number | D-0588-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SYNCHRONICITY SPA INC, DBA SUNTE, Las Vegas, NV, United States |
| Recall initiated | 2024-05-24 |
| Classified | 2024-07-08 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, FR, HK, KY, SG, TW |
| Quantity | 1,902 tubes |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 00854245006187 |
| NDC | 69949-0151, 69949-0151-01, 69949-0152, 69949-0152-01, 69949-0153, 69949-0153-01, 69949-0154, 69949-0154-01, 69949-0155, 69949-0155-01, 69949-0156, 69949-0156-01, 69949-0157, 69949-0157-01 |
| Lot numbers | 115BU |
| Expiration dates | 2025-06-30 |
Product
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
Reason for recall
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0588-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.