CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Cyclospora infections. At this time, there is no evidence to suggest that this cluster of illnesses is related to the  Cyclosporaoutbreak linked to Del Monte fresh produce vegetable trays.

As of August 23, 2018 (12pm EDT), a total of 507 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states and New York City. Note, the Connecticut, New York City, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.

Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 21). Ill people range in age from 14 to 91 years old, with a median age of 52. Sixty-six percent (66%) are female. At least 24 people have been hospitalized; no deaths have been reported.

Illnesses that started after July 12, 2018 might not have been reported yet due to the time it takes between when a person becomes ill and when the illness is reported. For Cyclospora infections, this can take up to six weeks.

Epidemiologic evidence indicates that salads purchased from McDonald’s restaurants are one likely source of these infections. The investigation is ongoing, and FDA is working to determine the sources of the ingredients that were in common to the salads served at McDonald’s.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.