FDAClass IIMarch 17, 2021

Sunstar G.u.m. Hydral DRY Mouth Relief On-the-go Oral recall: Contamination

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…

Why was Sunstar G.u.m. Hydral DRY Mouth Relief On-the-go Oral recalled?

The product may be contaminated with Burkholderia cepacia

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot codes within expiry

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…
Recalling firm
Sunstar Americas, Inc.
Quantity
56960 bottles
Distribution
US Nationwide distribution.
Recall date
March 17, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls