Z-1182-2021Class II

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 -

Name: Z-1182-2021 SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 -
Creator: Sunstar Americas, Inc.
Published: 2021-02-18
License: https://open.fda.gov/license/

Sunstar Americas, Inc. / initiated 2021-02-18 / Terminated / root cause: manufacturing process

FDA source

Sunstar Americas, Inc. began a recall of 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... on 2021-02-18. FDA classified it as Class II and gives the reason as "The product may be contaminated with Burkholderia cepacia". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1182-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-18
Posted: 2021-03-05
Terminated: 2024-09-30
Recalling firm: Sunstar Americas, Inc.
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, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.
Product code: LFD Saliva, Artificial
Reason for recall: The product may be contaminated with Burkholderia cepacia
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter and public notice on 02/18/2021. The letter stated that hazard and requested the return of the product.
Quantity in commerce: 56960 bottles
Distribution: US Nationwide distribution.
Product codes and lots: All lot codes within expiry

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1182-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1182-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-05

Product code LFD

K181134UnclassifiedG•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc. / cleared 2018-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)