Outbreaks & Recalls

12 Active FDA Investigations With 8 Ongoing to Pay Attention To

There are currently 12 active FDA investigations consumers should be paying attention to. Eight of which continue to include new cases.

Here’s what you need to know about these active FDA investigations and what you should look out for.

12 Active FDA Investigations

As the year winds down, the U.S. Food and Drug Administration (FDA) remains quite active.

The FDA active investigations table currently includes 12 active outbreaks with a total of 583 included cases. At least 279 hospitalizations have been reported.

Some of these investigations have been going on for months. For example, the Diamond Shruumz-Brand Chocolate Bars, Cones, and Gummies associated with seizures, central nervous system depression, agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting began in June.

The most recent outbreak was just added to the table last week.

Largest Outbreak So Far Is Diamond Shruumz-Brand Products

So far, the largest active outbreak involves Diamond Shruumz-brand products. As of November 13, 2024, there have been at least 104 illnesses and 34 hospitalizations included in this active outbreak. One death has been reported.

The outbreak illnesses were traced back to Diamond Shruumz-brand chocolate bars, cones, and gummies containing muscimol, psilocin, and other contributing adulterants.

McDonald’s Onion E. coli Outbreak – Biggest Outbreak in the News Right Now

Unless you’ve been living under a rock or on a deserted island with no wifi, you have likely heard of the E. coli outbreak linked to onions, most notably connected to McDonald’s. Originally announced on October 23, 2024, this outbreak has grown to 104 illnesses, 34 hospitalizations, and one death a of the latest data published on November 13, 2024.

Newest E. coli Outbreak Announced November 6, 2024

The newest E. coli O121:H19 outbreak was announced on November 6, 2024. So far, no product has been connected to the 33 associated cases. Traceback investigation activities have been initiated. It may take some time for the additional steps of onsite inspection and sampling activities to begin. The organization is still in the data gathering phase right now.

Other E. coli Outbreak Active FDA Investigations

Not including the infamous McDonald’s onions E. coli outbreak and the newest one just mentioned, there are three other E. coli outbreaks on the FDA’s active list.

E. coli O26:H11 Outbreak Announced October 30, 2024

Additional cases have been added to the E. coli outbreak initially announced on October 30, 2024. So far, nine cases of E. coli infections have been associated with this outbreak. Onsite inspection and sample collection activities have been initiated. The source of this outbreak may be announced soon.

E. coli O157:H7 Outbreak Announced August 28, 2024

The potentially life-threatening Shiga toxin-producing E. coli O157:H7 outbreak initially announced on August 28, 2024 has been linked to 28 cases. This investigation has progressed to onsite inspection and sample collection activities. The source for this outbreak may be announced soon as well.

Current Listeria monocytogenes Outbreak Active FDA Investigations

The FDA is currently investigating two Listeria monocytogenes outbreaks. One more recent, and one that has been on the organization’s radar since late summer.

Listeria monocytogenes Outbreak Announced on October 23, 2024

The most recent Listeria monocytogenes outbreak investigation was announced on October 23, 2024. While no product has been identified in this outbreak, onsite inspection and sampling activities have been initiated. The source of this outbreak that has so far sickened four people may be announced soon.

Listeria monocytogenes Outbreak Announced August 21, 2024

The Listeria monocytogenes outbreak announced on August 21, 2024 has moved to the sampling phase of the investigation. However, no onsite inspection has been performed. The FDA continues to search for the source of the Listeria monocytogenes outbreak that has sickened at least four people.

Current Salmonella Outbreak Active FDA Investigations

The FDA is currently investigating three separate Salmonella outbreaks. So far, only one has shown promising movement toward identifying a source.

Salmonella Thompson Outbreak Announced October 17, 2024

The most recent Salmonella outbreak involves Salmonella Thompson. This outbreak, announced on October 17, 2024 has been linked to 25 cases so far. While traceback investigation activities have been initiate, no onsite inspection or sampling has been performed at this time.

Salmonella Liverpool Outbreak Announced October 9, 2024

No movement has been made on the current Salmonella Liverpool outbreak investigation. So far, three people have been associated with the same Salmonella illness. However, no FDA traceback investigation activities have been initiated for this outbreak.

Salmonella Typhimurium Outbreak Announced June 19, 2024

Despite a Salmonella Typhimurium investigation being announced on June 19, 2024 and onsite inspection and sampling activities, no source has been identified in this outbreak that has sickened at least 90. It is unlikely that a source will be identified for this outbreak.

Current Cyclospora Active FDA Investigations

Two current Cyclospora active investigations remain on the FDA outbreak investigation table. The two outbreaks involving Cyclospora cayetanensis have underwent sampling activities and onsite inspections, but no source has been identified.

The first investigation involving 47 cases was announced on July 31, 2024. The second investigation involving 61 cases was announced the following week on August 7, 2024.

Have You Become Sick with E. coli, Listeria, Salmonella, or Cyclospora Infections?

Participant data is one of the most important factors of an outbreak investigation. Of course, laboratory analysis can help connect outbreak patients with each other. But questions about where sickened people have eaten, what they have eaten, and when can help narrow down a source.

Foodborne illness symptoms often involve diarrhea and/or vomiting, but the specific symptoms and onset period can help narrow down the source and connect additional probable cases to existing outbreaks.

Have you experienced any of these foodborne illness symptoms?

E. coli Symptoms

Symptoms of an E. coli infection often include severe stomach cramps, diarrhea (often bloody), and vomiting around three to four days after exposure. About five to ten percent of people diagnosed with E. coli develop a life-threatening type of kidney failure known as hemolytic uremic syndrome (HUS).

Listeria Symptoms

Listeria symptoms vary depending on whether or not the person is pregnant and often begin about two weeks after exposure.

For those who are not pregnant, symptoms often include fever and flu-like symptoms (muscle aches, fatigue, etc.). Other symptoms may include headache, stiff neck, confusion, loss of balance, and seizures.

People who are pregnant often experience more mild symptoms but more serious complications. Listeria infections during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.

Salmonella Symptoms

Salmonella infection symptoms often involve diarrhea (sometimes bloody), fever, stomach cramps and vomiting. These symptoms can appear anywhere from six hours to six days after exposure.

Cyclospora Symptoms

Symptoms of Cyclospora infections include watery diarrhea, loss of appetite, weight loss, stomach cramps, bloating, increased gas, nausea, and fatigue. These often begin about a week after exposure.

The Lange Law Firm Can Help!

If you have become sick with a foodborne illness and wish to make a legal claim, The Lange Law Firm, PLLC has a food poisoning lawyer that can help!

The burdens of foodborne illness add up. Medical bills, missed work, caring for a sick family member, and other aspects of recovery can be difficult to overcome.

Call (833) 330-3663 or send an email for a free, no obligation consultation.

By: Heather Van Tassell (contributing writer, non-lawyer)

Heather Van Tassell

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