Class II — Sunstar Americas, Inc.
| Recalling firm | Sunstar Americas, Inc. |
|---|---|
| Registered facility | SUNSTAR AMERICAS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The product may be contaminated with Burkholderia cepacia |
| Product | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth. |
| Quantity | 56960 bottles |
| Distribution | US Nationwide distribution. |
| Initiated | 2021-02-18 |
| Classified | 2021-03-05 |
| Terminated | 2024-09-30 |
| Recall number | Z-1182-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sunstar Americas, Inc. (Z-1182-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87371/
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