FDA Recalls September 10 - 15, 2025

Food and Beverage Recalls

CHETAK LLC GROUP recalls Deep Frozen fruits and vegetables

Chetak LLC Group Expands Voluntary Product Recall to Include Additional Frozen Vegetable and Fruit Products Due to Possible Health Risk

Collectively (“Chetak”) is expanding its voluntary recall, initiated July 16, 2025, to include several lots of Deep-branded frozen vegetables and fruit products due to possible Salmonella contamination. The recall is limited to frozen vegetable and fruit products as discussed further below.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Gina Marie Bakery recalls No Brand Cookies

Gina Marie Bakery of Waterbury Issues Recall of Cookies Due to Undeclared Almonds, Sesame and Food Dyes

The cookies involved in this recall are:

-Italian Mixed Vanilla Cookies for Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1

-Italian Sesame Cookies for Undeclared Yellow 5, Red 40, Yellow 6

-Vanilla Chocolate Dipped Cookies for Undeclared Red 40

-Vanilla with Apricot Jam Cookies –for Undeclared Red 40 and Yellow 6

-Toasted Almond & Cherry Biscotti – for Undeclared Red 40

-Vanilla Cookies with Raspberry Peach Jam – for Undeclared Red 3 and Blue 1

Gina Marie Bakery of Waterbury, CT is recalling 1lb and 2 lb packages of the above-mentioned cookies because they contain undeclared allergens. People who have allergies to nuts, sesame seeds and/or food dyes run the risk of serious or life-threatening allergic reaction if they consume these products.

Gooder Foods, Inc recalls Goodles Flavored pasta

Gooder Foods Issues Allergy Alert On - Undeclared Milk and Cashews in Goodles Vegan is Believin’ – Plant Based White Cheddar with Spirals and Goodles Here Comes Truffle – Creamy Truffle Flavored Cheddar and Shells

FOR IMMEDIATE RELEASE — Santa Cruz, CA, September 10, 2025 — Gooder Foods, Inc. is recalling 5 lots of Vegan Is Believin’ – Plant Based White Cheddar with Spirals produced as they may contain milk, which is not listed on the label, and 3 lots of Here Comes Truffle – Creamy Truffle Flavored Cheddar and Shells, as they may contain cashew which is not listed on the label. The recalled lots were produced between April 7 and April 15, 2025.

Persons who have an allergy or severe sensitivity to milk and/or cashew may run the risk of a serious or life-threatening allergic reaction if they consume these products.

One Frozen, LLC recalls Good & Gather Frozen Burrito Bowl

One Frozen, LLC Voluntarily Recalls Good & Gather™ Southwest Style Burrito Bowl Blend, Frozen, 12oz Bags Due to Undeclared Shrimp Allergen

One Frozen, LLC of Rochester, NY, is voluntarily recalling certain lots of Good & Gather™ Southwest-Style Burrito Bowl Blend (frozen, 12oz bags) because the product may contain shrimp (crustacean shellfish) that was not declared on the ingredient label of the product. People who have an allergy or severe sensitivity to shellfish run the risk of a serious or life-threatening allergic reaction if they consume this product.

Good & Gather™ Southwest-Style Burrito Bowl Blend were distributed through Target retail stores nationwide, in all 50 states. The distribution from One Frozen, LLC to Target began on 4/17/2025.

Medical Device Recalls

BD recalls BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 when used with a subset of compatible pump infusion sets, as compared to the performance described in the user manual. The update includes an expansion of 15 additional impacted pump infusion sets included in the recall, as well as new corrective actions and risk information. The 15 additional sets had been previously discontinued but may remain in inventory based on the expiration date.

This issue was identified through internal testing and, to date, BD has not received any complaints associated with this issue. The affected products have the potential to result in patient death or serious adverse events, with a particular higher risk to vulnerable patient populations such as neonates and critically ill patients. The recall has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA).