Sunstar Americas, Inc. recalls
Every recall we track for Sunstar Americas, Inc. — 6 in all, from 2020–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Sunstar Americas, Inc. peaked in 2021 (3); 6 since 2017.
All FDA recall records for Sunstar Americas, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 2 | 2 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Sunstar Americas, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Sunstar Americas, Inc. recalls
6 shown- Lower riskMedical device
Sunstar Americas, Inc. recalls BUTLER Clear Dip, 12 bottles/case
Sunstar recalls Butler Clear Dip 12-bottle cases with specific SKUs due to lack of premarket clearance. Consumers should check their product details to determine if affected.
SunstarJan 14, 2022 - Lower riskMedical device
Sunstar Americas, Inc. recalls SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat
Sunstar recalls Perioshield oral rinse due to potential contamination with Burkholderia bacteria. Affected SKUs include 1775P and 1775R with specific lot numbers. Consumers should check their product details to determine if recalled.
SunstarMay 21, 2021 - Lower riskMedical device
Sunstar Americas, Inc. recalls SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Sunstar recalls 16 fl oz Butler Clear Dip due to Burkholderia contaminans risk. Affected lots: 532952, 535180, 536513, 536514, 53948:551038, 551039. Stop using if contaminated.
SunstarMar 23, 2021 - Lower riskMedical device
Sunstar Americas, Inc. recalls 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
Sunstar recalls 2 fl oz dry mouth relief spray due to potential Burkholderia cepacia contamination. Consumers should check product UPC 70942 30713 0 for affected lots.
SunstarFeb 18, 2021 - UnratedDrug
Sunstar Americas, Inc. recalls Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC
Sunstar recalls Paroex oral rinse due to potential Burkholderia cepacia contamination from manufacturing issues. Affected lots were sold from Dec 2020 to Sep 2022. Consumers should check their product details and contact Sunstar for guidance.
SunstarDec 28, 2020 - UnratedDrug
Sunstar Americas, Inc. recalls Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC
Sunstar recalls Paroex (chlorhexidine gluconate) oral rinse due to Burkholderia lata contamination. This prescription rinse may cause infection if used. Consumers should contact Sunstar for details.
SunstarOct 27, 2020
Sunstar Americas, Inc. recall questions
How many recalls has Sunstar Americas, Inc. had?
6 recalls from Sunstar Americas, Inc. are on record with U.S. safety agencies, from 2020–2022 (4 medical device, 2 drug).
What is the most recent Sunstar Americas, Inc. recall?
Sunstar Americas, Inc. recalls BUTLER Clear Dip, 12 bottles/case, dated Jan 14, 2022. Every Sunstar Americas, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Sunstar Americas, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Sunstar Americas, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.