Food/Recall·openFDA/food

Specialty Bakers, LLC — Class II: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximate

MediumPublished Jul 15, 2026· AI-analyzed Jul 22, 2026View original FDA source
AI-generated regulatory interpretation. The four sections below are an analyst-style summary produced by an AI model from the original FDA source. Always verify against the source before any regulatory, clinical, or commercial decision.
What happened

Specialty Bakers, LLC has initiated a Class II recall for Vanilla Dessert Shells (sold under the Giant brand) due to an undeclared soy allergen. The recall involves frozen 6-pack plastic-wrapped trays packed 24 per case.

Who it affects

This recall affects Specialty Bakers, LLC and retail partners distributing Giant brand vanilla dessert shells, as well as food safety and regulatory professionals overseeing allergen control programs.

Why it matters

The classification suggests that consumption of the product may cause temporary or medically reversible adverse health consequences due to the undeclared allergen. For the manufacturer, this indicates a failure in the allergen control plan or labeling verification process, potentially requiring an update to Hazard Analysis and Risk-Based Preventive Controls (HARPC).

Practical takeaway

Regulatory and QA teams should conduct a label-to-formulation audit for all frozen dessert products to ensure soy-based emulsifiers or ingredients are correctly declared. Firms should review packaging line clearance procedures for plastic-wrapped trays to prevent mislabeling risks.

FDA source material

Class II. Reason: Undeclared Allergen (Soy). Product: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen. Firm: Specialty Bakers, LLC (Marysville PA United States). Status: Ongoing.

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