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Unrated Drug recall · FDA · Published December 8, 2025

ORL Kids Mouthwash Bubblegum Flavor Recall: CPG Deviations Risk

ORL recalls Bubblegum flavored kids mouthwash due to cGMP deviations. Affected lots: 250505P9, expiring May 27. Consumers should check labels and contact company for details.

🇺🇸 FDA recall #D-0252-2026DrugORL ›
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Contact the company

Recalling firmSignature Formulations, LLC5446 W Roosevelt St Ste 101 · Phoenix, AZ 85043-2729
✎ GovInfoNow plain-language explainer

What happened, in plain English

ORL is recalling Bubblegum flavored kids mouthwash because of manufacturing quality issues. This could affect product safety, though no specific injuries have been reported. Read more at govinfonow.com/recall/31622-orl-kids-mouthwash-bubblegum-flavor-recall-cpg-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31622-orl-kids-mouthwash-bubblegum-flavor-recall-cpg-deviations-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0252-2026

Cite this page

“ORL Kids Mouthwash Bubblegum Flavor Recall: CPG Deviations Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/31622-orl-kids-mouthwash-bubblegum-flavor-recall-cpg-deviations-risk. Based on FDA recall #D-0252-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0252-2026%22&limit=1).

Why it’s dangerous

The product was made under cGMP (current Good Manufacturing Practice) deviations, which means the manufacturing process didn't follow safety standards. This could lead to unsafe ingredients being in the product, especially for children who might ingest it.

Who’s affected

Parents and caregivers of children who own this specific mouthwash product. Children using the product are at higher risk due to potential ingestion of unsafe ingredients.

How to tell if you have this one

Check for the label 'ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle' and lot number 250505P9. The product expires May 27.

  • Brand
    ORL
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    AZ only
Recall numberProduct, codes & lotsQuantity
D-0252-2026ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA; Lot #: 250505P9, Exp. Date 05/27570 bottles
D-0253-2026ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA; Lot #: 250520P4, Exp. Date 05/271,458 containers
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot number 250505P9 and expiration date of May 27 on the bottle.

Where it went and when

Where it was distributed

Distributed in Arizona.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “AZ only” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Dec 8, 202512. FDA classified it Class II: Jan 5, 202623. Published in FDA’s Enforcement Report: Jan 14, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0252-2026 (December 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0252-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA