The FDA investigation suggests that romaine lettuce associated with the outbreak comes from areas of California that grow during the summer months and that the outbreak appears to be related to "end of season" romaine lettuce harvested from these areas.
The involved areas include the Central Coast growing regions of central and northern California.
The Centers for Disease Control is advising U.S. consumers not to eat any romaine lettuce in response to the outbreak.
The CDC also says retailers and restaurants should not serve or sell any romaine lettuce until more is learned about the outbreak.
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As of Monday, this outbreak has resulted in 43 people becoming ill in 12 states, with the last reported illness onset date being Oct. 31. An additional 22 people in Canada have become ill.
Officials say 32 people in 11 states were infected with the outbreak strain of Shiga toxin-producing E. coli between October 8 and October 31.
Thirteen people were hospitalized, including one person who developed a type of kidney failure.
No deaths have been reported.
The CDC advises anyone who has any type of romaine lettuce in his or her home should not eat it and should throw it away, even if some of it was eaten and no one has gotten sick.
This includes all types or uses of romaine lettuce, such as whole heads of romaine, hearts of romaine, and bags and boxes of precut lettuce and salad mixes that contain romaine, including baby romaine, spring mix, and Caesar salad.
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"Based on discussions with major producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date. Romaine lettuce entering the market can also be labeled as being hydroponically or greenhouse grown. If it does not have this information, you should not eat or use it," the FDA said. "If consumers, retailers, and food service facilities are unable to identify that romaine lettuce products are not affected - which means determining that the products were grown outside the California regions that appear to be implicated in the current outbreak investigation -- we urge that these products not be purchased, or if purchased, be discarded or returned to the place of purchase."
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According to the CDC, people usually get sick from Shiga toxin-producing E. coli two to eight days after swallowing the germ. Some patients may get a type of kidney failure called hemolytic uremic syndrome.
E. coli infection is usually diagnosed by testing a stool sample.
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If you have symptoms of an E. coli infection, talk to your healthcare provider.
Write down what you ate in the week before you started to get sick, and report your illness to the health department.
CLICK HERE for more on the outbreak from the CDC.
Note: Video is from a previous report.