CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Oral B Mouth Sore Rinse recalled by Family Dollar Stores

Family Dollar Stores is recalling Oral B Mouth Sore Rinse, distributed in 23 states. The recall was initiated on 4 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units sold at stores between June 1, 2023 and October 4, 2023.

Quantity recalled329,044 total units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0270-2024
FDA event ID: 93216
Recalling firm: Family Dollar Stores, Chesapeake, VA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Oct 2023
FDA classified: 7 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

4 Oct 2023	Recall initiated by company
7 Nov 2023	Classified by FDA	+34 days
15 Nov 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products were stored outside of labeled temperature requirements.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

ORAL B MOUTH SORE RINSE 237ML, SKU 999087

Where it was distributed

Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.

Alabama Arkansas Arizona California Colorado Florida Georgia Idaho Kansas Louisiana Mississippi Montana North Dakota Nebraska New Mexico Nevada Oklahoma Oregon South Dakota Texas

Stores named: Dollar Tree

Questions about this recall

Why was it recalled?

Products were stored outside of labeled temperature requirements.

Which lots are affected?

All units sold at stores between June 1, 2023 and October 4, 2023.

Where was it sold?

Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 93216

This product is part of a recall event; the main page for the event is Medic's Choice Contact Lens Solution recalled by Family Dollar Stores.

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023	CLASS II	Medic's Choice Contact Lens Solution recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	Dentemp One Step recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	First Response recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	Arc Teeth Whitening Pen recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	Clearblue Smart Countdown Prgncy Tst recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	Goodsense Denture Cleanser Grn Tab recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	At Home Marijuana Test Strip recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	Fixodent ORG Cream recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023	CLASS II	Veriquick Pregnancy Test recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states

More recalls from Family Dollar Stores

All 149

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023Device	CLASS II	Veriquick Pregnancy Test recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023Device	CLASS II	Fixodent ORG Cream recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023Device	CLASS II	At Home Marijuana Test Strip recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023Device	CLASS II	Goodsense Denture Cleanser Grn Tab recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states
15 Nov 2023Device	CLASS II	Clearblue Smart Countdown Prgncy Tst recalled by Family Dollar Stores	Family Dollar Stores	Temperature Abuse	23 states

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide