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Lower risk Medical device recall · FDA · Published February 18, 2021

Sunstar G.U.M. Hydral Dry Mouth Relief Spray Recall: Contamination Risk

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.

🇺🇸 FDA recall #Z-1182-2021Medical deviceSunstar ›
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Recalling firmSunstar Americas, Inc.301 E Central Rd · Schaumburg, IL 60195-1901
✎ GovInfoNow plain-language explainer

Sunstar is recalling its G.U.M. Hydral Dry Mouth Relief oral spray because it may be contaminated with Burkholderia cepacia. This bacteria can cause serious health issues, especially for people with weakened immune systems. Read more at govinfonow.com/recall/63264-sunstar-g-u-m-hydral-dry-mouth-relief-spray-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/63264-sunstar-g-u-m-hydral-dry-mouth-relief-spray-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1182-2021

Cite this page

“Sunstar G.U.M. Hydral Dry Mouth Relief Spray Recall: Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63264-sunstar-g-u-m-hydral-dry-mouth-relief-spray-recall. Based on FDA recall #Z-1182-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1182-2021%22&limit=1).

The FDA announced on Feb. 18, 2021, that Sunstar Americas, Inc. voluntarily recalled SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray due to potential contamination with Burkholderia cepacia. The recall affects 56,960 bottles distributed nationwide.

How to tell if you have it

  • Brand: Sunstar
  • Product: SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray
  • Size: 2 FL.OZ.
  • UPC: UPC0 70942 30713 0
  • Lot codes: All lot codes within expiry

The hazard

The product may be contaminated with Burkholderia cepacia. 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.

Context

GovInfoNow's records show Sunstar Americas, Inc. has 5 other recalls on record since Oct. 27, 2020. Other recent recalls of similar products include Medline Centurion Shave Kits Recall (March 16, 2026), Medline Convenience Kits Recall (Aug. 11, 2026), and Avanos Medical PEG Kit 20 Fr PUSH OTW Recall (April 30, 2026).

How to tell if you have this one

Check the UPC code on the product label: 70942 30713 0. The product is a 2 fl oz oral spray designed for dry mouth relief.

  • Brand
    Sunstar
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the UPC code 70942 30713 0 on the product label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

1. Firm started the recall: Feb 18, 202112. FDA classified it Class II: Mar 5, 202123. Published in FDA’s Enforcement Report: Mar 17, 202134. FDA terminated the recall: Sep 30, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1182-2021 (February 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1182-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA