FDA Device recall Z-0720-2022
BUTLER Clear Dip, 12 bottles/case
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of BUTLER Clear Dip, 12 bottles/case by Sunstar Americas, citing product lacks premarket clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0720-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-14 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sunstar Americas |
| Distribution | US |
Product
BUTLER Clear Dip, 12 bottles/case
Reason
Product lacks premarket clearance.
Identifiers
| code_info | SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Sunstar Americas
- SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by p…
FDA Device · Class II · 2021-06-16 · Sunstar Americas - SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Device · Class II · 2021-04-21 · Sunstar Americas - 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 wat…
FDA Device · Class II · 2021-03-17 · Sunstar Americas - Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02
FDA Drug · Class II · 2021-01-20 · Sunstar Americas - Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02
FDA Drug · Class I · 2020-12-02 · Sunstar Americas
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0720-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.