FDA issues Class II recall on over 2 million baked goods: Products affected, locations, and more details explored

The U.S. Food and Drug Administration (FDA) has escalated a voluntary recall to a Class II recall involving more than 2 million baked goods due to potential contamination with Listeria monocytogenes. The action was initiated against Indiana-based manufacturer FGF Brands on January 5, 2025, and was upgraded on February 7, 2025.

The recall affects FGF Brands' products sold at Dunkin' locations in the U.S. and private brands across the U.S. and Canada.

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Products affected by the Class II recall

15 Dunkin' items were included in the Class 11 recall (Image via Pexels)

The Class II recall includes 2,017,614 cases of baked goods, spanning 60 types of pastries produced before December 13, 2024, as per a CBS News report. Among these are 15 Dunkin items, such as Just Baked Yeast Rings, Coffee Rolls, Eclairs, and seasonal offerings like Pumpkin Cake Munchkins. Private-label products sold in grocery stores are also included, though specific brands were not disclosed.

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Reason for the Class II recall

The FDA defines a Class II recall as one where exposure to a product may cause temporary or medically reversible health effects, with serious consequences deemed unlikely.

While no illnesses have been reported, FGF Brands cited "non-product related findings" at a U.S. facility as the basis for the precautionary measure. The company stated no doughnuts or food contact surfaces tested positive for listeria.

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Listeria risks and CDC guidance

CDC data says listeria infection causes around 260 deaths a year (Image via Getty)

Listeria monocytogenes is a bacterium known to cause foodborne illness. Listeria monocytogenes infections are rare but pose severe risks to pregnant individuals, newborns, older adults, and those with weakened immune systems.

The Centers for Disease Control and Prevention (CDC) notes symptoms like fever, muscle aches, headaches, and, in severe cases, confusion or seizures. Approximately 1,600 listeria infections occur annually in the U.S., resulting in about 260 deaths, according to CDC.

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Company response and consumer steps

The company's response to the recent media coverage (Image via FGF Brands)

FGF Brands emphasized the recall was completed in early January, asserting that "all donuts are completely safe to eat" and no affected products remain on shelves. The FDA has not issued specific instructions regarding what consumers should do if they possess any of the recalled baked goods; however, it is standard practice to discard any products that may be contaminated.

This recommendation is part of the broader response initiated under the current Class II recall. Consumers who have purchased items from the affected batches are encouraged to contact FGF Brands directly with any concerns. Questions can be directed to FGF via phone (905-761-3333), email ([email protected]), or their website contact form.

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Regulatory context and prior recalls

This marks the first major Class II recall of 2025 involving baked goods. In December 2024, Braga Fresh recalled broccoli florets sold at Walmart due to listeria concerns, though no illnesses were reported. The FDA's database lists the FGF recall as "ongoing," with no termination date specified.

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The Class II recall of over 2 million baked goods underscores the food industry's emphasis on precautionary measures, even without confirmed contamination. While FGF maintains its products are safe, the FDA urges consumers to heed recalls to mitigate potential risks. Updates on the recall status are available via the FDA's official portal.