Exact FDA event identifier

Event 98131

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 08, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Signature Formulations, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

D-0252-2026

Recall number: D-0252-2026
Initiated: December 08, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Signature Formulations, LLC
Quantity: 570 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: 250505P9, Exp. Date 05/27

Distribution pattern

AZ only

drug · product 2 of 2

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

D-0253-2026

Recall number: D-0253-2026
Initiated: December 08, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Signature Formulations, LLC
Quantity: 1,458 containers

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: 250520P4, Exp. Date 05/27

Distribution pattern

AZ only