Recall Register

Sunstar Americas, Inc.: FDA recalls

FDA enforcement reports name Sunstar Americas, Inc. as the recalling firm in 6 events. The events have 6 product records. The recalls started from 2020 to 2022.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of Sunstar Americas, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
14 Jan 2022BUTLER Clear Dip, 12 bottles/caseDeviceClass II1Terminated
21 May 2021SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.DeviceClass II1Terminated
23 Mar 2021SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PADeviceClass II1Terminated
18 Feb 2021SUNSTAR 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…DeviceClass II1Terminated
28 Dec 2020Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, ILDrugClass II1Ongoing
27 Oct 2020Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.DrugClass I1Completed

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Sunstar Americas, Inc.: events for each product type
TypeEvents
Device4
Drug2
Sunstar Americas, Inc.: events in each class
ClassEvents
Class II5
Class I1
Share of the events of the firm in Class I
17%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Sunstar Americas, Inc., by the year that the recall started. The largest year is 2021, with 3 events.

Official channels

Cite this page

Recall Register. Sunstar Americas, Inc.: FDA recalls. https://recallregister.com/firm/sunstar-americas-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Sunstar Americas, Inc. have?
Class II: 5 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Sunstar Americas, Inc. have?
Device: 4 events. Drug: 2 events.
What is the newest FDA recall of Sunstar Americas, Inc.?
FDA event 89460, which the firm started on 14 Jan 2022. The first product in the record is: BUTLER Clear Dip, 12 bottles/case
How many FDA recalls of Sunstar Americas, Inc. have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.