CLASS II ONGOING Drug recall · Reported 14 Jan 2026 · FDA Enforcement Report
ORL Kids Mouthwash, Bubblegum Flavor per, ORL Labs, LLC recalled
Signature Formulations is recalling ORL Kids Mouthwash, Bubblegum Flavor per, ORL Labs, LLC, Scottsdale, Arizona USA, distributed in Arizona. The recall was initiated on 8 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0252-2026
- FDA event ID
- 98131
- Recalling firm
- Signature Formulations, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Dec 2025
- FDA classified
- 5 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Sunscreen & Personal Care
Timeline
| 8 Dec 2025 | Recall initiated by company | |
| 5 Jan 2026 | Classified by FDA | +28 days |
| 14 Jan 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Where it was distributed
AZ only
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot #: 250505P9, Exp. Date 05/27
Where was it sold?
AZ only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
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
1 other product · FDA event 98131| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ORL Kids Natural Toothpaste, Bubblegum Flavor, ORL Labs recalled | Signature Formulations | Manufacturing (CGMP) Deviations | AZ |
More recalls from Signature Formulations
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ORL Kids Natural Toothpaste, Bubblegum Flavor, ORL Labs recalled | Signature Formulations | Manufacturing (CGMP) Deviations | AZ |