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The FDA has begun traceback and sample collection in an outbreak of E. coli O121:H19 linked to frozen falafel sold at Aldi stores in 36 states.

At least 20 people had been confirmed sick as of Oct. 7, according to the Food and Drug Administration. Sick people have been confirmed in Florida, Iowa, Kansas, Michigan, Ohio and Wisconsin. The most recent illness onset was Sept. 13.

Five of the patients have been so ill that they required admission to hospitals. The count of sick people is expected to increase because of the time it takes for testing, diagnosis, confirmation testing and notification of state and federal officials.

The manufacturer of the falafel, Cuisine Innovations, has initiated a recall of some of its products and ceased production of them. Recalled products are Earth Grown vegan traditional falafel and garlic & herb falafel distributed and sold exclusively by ALDI. Additional information on recalled products is available in the firm’s recall notice, posted by the FDA.

The FDA has not reported how the product became contaminated.

There is concern that consumers may still have unused product in their homes because of its long shelf life. The products’ shelf life when frozen is 18 months.

Other outbreak updates

• For an outbreak ofE. coli O157:H7 in an unidentified product, the FDA investigation has closed with no further information released.

• For a Salmonella Senftenberg outbreak from a not yet identified food, the patient count has increased from 33 to 34. Traceback has begun but FDA has not reported what is being traced.
• A Salmonella Litchfield outbreak has sickened at least 28 patients. The source of the pathogen has not yet been identified. The FDA has initiated traceback efforts but has not reported what food or foods are being traced.
• For the outbreak of Cyclospora cayetanensis in an unidentified product the patient count has increased from 42 to 43 cases. The FDA initiated traceback and testing efforts but has not reported what food is the subject of those efforts. The investigation remains open even though the outbreak is over.

• For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. It reportied that six patients from six different states have been confirmed. Five have been hospitalized, according to the CDC.
• An investigation related to adverse effects associated with Daily Harvest brand frozen Leeks & Lentils Crumbles is ongoing. The company has received more than 470 complaints of illnesses and as of its most recent report on Sept. 15 the FDA had received 386 complaints. Some of the patients have gone into liver failure and at least 25 have had to have their gallbladders removed. The FDA is working on traceback efforts and has begun on-site inspection and product testing. Some testing has revealed that tara flour is an ingredient unique to the Daily Harvest crumbles product and could be related to the illnesses.
• The FDA is conducting an on-site inspection at Big Olaf Creamery in Florida, which has been deemed to be behind an 11-state outbreak of Listeria infections. The state of Florida closed the business several weeks ago after tests found multiple places of contamination with Listeria monocytogenes in the plant. Testing also showed Listeria in 16 of 17 flavors of the company’s ice cream. At last count, the outbreak had sickened 25 patients with one having died. A pregnant woman also miscarried. Twenty-four of the patients have required hospitalization.
• An outbreak of infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.