RecallHawk
Class II Recall

Carley s Soft Baked Iced Lemon Cookies, 5.34oz Plastic Tray, clear film overwrap w/ Label, 12 units per case

Carley's Inc.

Summary

The FDA issued a Class II for Carley s Soft Baked Iced Lemon Cookies, 5.34oz Plastic Tray, clear film overwrap by Carley's Inc.. Reason: Product has a misbranded Yellow Color. Identified on label at Artificial Yellow Color , and it should be identified as FD&C Yellow #5.

Details

Source

Food Recall

External ID

H-0088-2025

Action Date

2025-07-02

Status

Terminated

Category

food

Product Description

Carley s Soft Baked Iced Lemon Cookies, 5.34oz Plastic Tray, clear film overwrap w/ Label, 12 units per case

Lot/Code Info: UPC Code: 7 40235 50011 0 Exp Date-Lot Code 01726-040225 11245-012825 031026-051425 061925-082324 080525-100924 081725-102124 091025-111424 061925-082324 112425-012825

Quantity Affected: 5,826 cases

Reason for Recall

Product has a misbranded Yellow Color. Identified on label at Artificial Yellow Color , and it should be identified as FD&C Yellow #5

Distribution

Product is shipped to wholesalers who further distribute to retail stores. Wholesalers are located in IL, MI, IA, LA, MD, PA, VA, MN, AL, TX, GA, SC, NY, NC, WV,

Type: Voluntary: Firm initiated

Recall Initiated: 2025-06-06

Company

Carley's Inc.

Lake Forest, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 69 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carley's Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Carley's Inc. have FDA actions?

This is the only FDA action we have on record for Carley's Inc. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "H-0088-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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