The Recall Desk

Manufacturer

Sunstar Americas, Inc.

6 recalls in our database name Sunstar Americas, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
2
Most recent
2022-03-09

Of the 6 recalls from Sunstar Americas, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (33%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-0720-2022·2022-03-09

    BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance

    Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.

    Product
    BUTLER Clear Dip, 12 bottles/case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2021·2021-06-16

    Sunstar G.U.M Perioshield Oral Rinse Recalled Due to Bacterial Contamination

    Sunstar Americas is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse 300mL (SKU 1775P, 1775R) due to potential contamination with Burkholderia bacteria.

    Product
    SUNSTAR 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2021·2021-04-21

    Sunstar Butler Clear Dip Recalled for Burkholderia Contamination

    Sunstar Americas is recalling 19,471 bottles of Butler Clear Dip due to potential contamination with Burkholderia contaminans.

    Product
    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1182-2021·2021-03-17

    Sunstar G.U.M. Hydral Dry Mouth Spray Recalled for Bacterial Contamination

    Sunstar Americas is recalling 56,960 bottles of G.U.M. Hydral Dry Mouth Relief Oral Spray due to potential Burkholderia cepacia contamination.

    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, mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0222-2021·2021-01-20

    Paroex Oral Rinse Recalled for Potential Bacterial Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to potential Burkholderia cepacia complex contamination and manufacturing facility violations.

    Product
    Paroex (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, IL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0103-2021·2020-12-02

    Paroex Oral Rinse Recalled for Burkholderia lata Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to microbial contamination with Burkholderia lata. The recall covers specific lots distributed nationwide.

    Product
    Paroex (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.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Sunstar Americas, Inc. (United States)

company in Schaumburg, United States

Country
United States

Official website

Source: Wikidata (Q140046490), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.