Multi-event December 2025 FDA Recall Drug by Signature Formulations, Llc

This Multi-event Class II drug recall was voluntarily initiated by Signature Formulations, Llc on December 8, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in AZ only and the recall is currently ongoing.

Reported Recall Events

D-0253-2026 ONGOING D-0252-2026 ONGOING

Recall Number: D-0253-2026

Reason for Recall
cGMP Deviations
Initiated
12-08-2025
Reported
01-14-2026
Quantity
1,458 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98131
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Signature Formulations, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ only
Product Description About Product Description
Full technical description of the product.
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

Batch or Lot Expiration Information

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

Recall Number: D-0252-2026

Reason for Recall
cGMP Deviations
Initiated
12-08-2025
Reported
01-14-2026
Quantity
570 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98131
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Signature Formulations, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ only
Product Description About Product Description
Full technical description of the product.
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

Batch or Lot Expiration Information

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