Food, drugs, devices › GlaxoSmithKline, LLC.

Device recall: Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened w

FDA enforcement event 66689 · Class II · initiated 17 Oct 2013 · status Terminated · terminated 26 Jul 2017

DeviceVoluntary: Firm initiated1 product recordZebulon, NC

GlaxoSmithKline, LLC. (Zebulon, NC) initiated this device recall on 17 Oct 2013; FDA lists 1 product record under event 66689, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 26 Jul 2017. Initiation: voluntary: firm initiated. GlaxoSmithKline, LLC. has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

GlaxoSmithKline, LLC., Zebulon, NC.

Reason for recall

"Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol."

Distribution

"Nationwide Distribution ."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0272-2014	Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth	483,204 bottles	Class II	Terminated	20 Nov 2013

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for GlaxoSmithKline, LLC.

Initiated	Product (first record)	Type	Class	Records
17 May 2024	Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table	Drug	Class III	1
12 Dec 2023	ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters t	Drug	Class III	1
13 May 2022	Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497	Drug	Class III	1
16 May 2017	Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx on	Drug	Class II	1
22 Mar 2017	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhaler	Drug	Class II	1
18 Jul 2016	Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709,	Drug	Class II	4
3 Dec 2015	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral I	Drug	Class II	1
13 Aug 2015	Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road	Drug	Class II	4
6 Nov 2013	Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containin	Drug	Class II	2
18 Jul 2013	TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp,	Drug	Class III	1

All 13 events for GlaxoSmithKline, LLC.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution ."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Jul 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.