CDC, several state and local health departments, and the U.S. Food and Drug Administration (FDA) are investigating reports of harmful reactions among people who received injections of counterfeit or mishandled botulinum toxin (commonly called “Botox”).

As of April 18, 2024, a total of 22 people from 11 states have reported harmful reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas. Harmful reactions occurred on dates ranging from November 4, 2023, to March 31, 2024. States reporting these reactions include California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas, and Washington.

Public health and regulatory officials have found that some people received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.

More information about the counterfeit products, including signs of counterfeit versions, may be found on FDA’s website.

People have reported experiencing

  • Blurry vision and double vision
  • Drooping eyelids
  • Difficulty swallowing
  • Dry mouth
  • Slurred speech
  • Difficulty breathing
  • Fatigue
  • Generalized weakness

Of 20 people with information available, 11 (55%) people were hospitalized and 6 (27%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Of seven people tested for botulism, six people had negative results. Results are pending for one person.

All reports came from people identifying as females, ranging in age from 25 to 59 years, with a median age of 41 years. Twenty (91%) people reported receiving botulinum toxin injections for cosmetic purposes. All people reported receiving these injections from unlicensed or untrained individuals or in non-healthcare settings, including homes and spas.

According to Texas news reports, two newborns living with their families in the same West Texas neighborhood were earlier this year diagnosed with botulism, a rare — and in some cases, fatal — illness caused by a toxin that attacks the body’s nerves.

The families, who live within blocks of each other, learned of the diagnosis in mid-January and early February.

A third newborn in the same neighborhood was previously diagnosed with botulism, which can cause difficulty breathing and muscle paralysis, in August.

Hospitals in Lubbock treated the three infants.

Local and state health officials said the types of botulism were different in each case, eliminating the need to issue an alert to others in the area, a decision which left the three families alarmed about the well-being of neighboring households with newborns.

“This isn’t a one-off, this isn’t the flu,” said Jana Bowman, mom to one of the infants. “Families need to know what it looks like so that they don’t have another baby sitting [at home] for eight hours when they could have been getting care.”

Two common ways infants contract botulism are through the environment and food. The Midland Health Department has not confirmed the cause of the exposure to the toxin that infected the three children, according to a spokesperson. However, the spokesperson ruled out food.

“For many infant botulism cases the specific source is never identified due to the fact that it can be environmental, usually via dust that is stirred up due to windy conditions, construction around the home, or through contact with parents who work outdoors,” the spokesperson said. “Based on our investigation we do not believe the source to be foodborne.”

Situation at a glance

On 12 September 2023, local public health authorities in France identified a cluster of 10 cases with suspected botulism, including one death. As of 14 September 2023, the National IHR Focal Point for France has notified WHO of a total of 15 cases of suspected botulism, including one death, reported in Bordeaux and Ile-de-France.

The epidemiological investigations indicated that the source of infection is the consumption of homemade preserved sardines , on different dates, at the same restaurant in Bordeaux during the week of 4–10 September 2023. The food item was made at the restaurant for consumption on premises. 

Due to the incubation period of up to eight days and the restaurant attracting international visitors during the Rugby World Cup, there is a possibility that additional cases among international visitors may be reported in France, or possibly outside France as travellers returned home, until 18 September.

Description of the situation 

On 12 September 2023, local public health authorities in France identified a cluster of 10 cases with suspected botulism, including one death. 

As of 14 September 2023, the National IHR Focal Point for France has notified a total of 15 cases of suspected botulism, including one death, reported in Bordeaux and Ile-de-France. Of these 15 cases, 10 have been hospitalised, with eight patients being admitted to an Intensive Care Unit. Fourteen out of the 15 cases are reported among foreign citizens identified from six countries in addition to France. These include Canada, Germany, Greece, Ireland, the United Kingdom of Great Britain and Northern Ireland, and the United States of America. All suspected cases consumed the same product (sardines in jars) on different dates at the same restaurant in Bordeaux during the week of 4–10 September 2023. The epidemiological investigations indicated that the source of infection is the consumption of homemade preserved sardines. The food item was produced and served at the restaurant.

Epidemiology of the Botulism 

Botulism is a serious neurological condition caused by a very potent toxin produced by the bacterium  Clostridium botulinum . It develops particularly in poorly preserved foods. Human botulism may refer to foodborne botulism, infant botulism, wound botulism, and inhalation botulism or other types of intoxication.

Foodborne botulism is a serious, potentially fatal disease. It is an intoxication caused by ingestion of potent neurotoxins—the botulinum toxins—formed in contaminated foods. Person-to-person transmission of botulism does not occur. The manifestations, or symptoms, of intoxication can vary, and  is characterized by descending, flaccid paralysis that can cause respiratory failure. Early symptoms include marked fatigue, weakness and vertigo, usually followed by blurred vision, dry mouth and difficulty in swallowing and speaking. Vomiting, diarrhoea, constipation and abdominal swelling may also occur. The disease can progress to weakness in the neck and arms, after which the respiratory muscles and muscles of the lower body are affected. There is no fever and no loss of consciousness. Symptoms usually appear from several hours up to 8 days following consumption of contaminated food.

Although botulism outbreaks are relatively rare, they are considered public health emergencies that require rapid recognition to identify the disease source, distinguish outbreak types (between natural, accidental or deliberate), prevent additional cases and effectively administer treatment to affected patients. Successful treatment depends significantly on early diagnosis and the rapid administration of the botulinum antitoxin and intensive respiratory care.

Incidence of botulism is low, but the mortality rate is high if prompt diagnosis and appropriate, immediate treatment is not given. The disease can be fatal in 5% to 10% of cases.

Public health response

  • On 11 September, food and serum samples were shipped to the French National Reference Center for Anaerobic Bacteria and Botulism, Institute Pasteur, Paris , and botulinum toxin was confirmed in serum samples and in a food sample (sardines) on 14 September 2023.  
  • The local health authorities inspected the restaurant and all products prepared by the restaurant have been recalled. On 13 September, the local health authorities held a press conference and informed the local healthcare professionals.
  • The national health authorities have issued risk communication advice to sensitize the health care workers about the symptomatology and treatment.
  • Information on cases reported among citizens from foreign countries have been shared with the relevant health authorities in those countries.

WHO risk assessment

Local investigations have identified an estimated 25 persons through credit card receipts who have been exposed (i.e., who likely consumed the suspect food item). The exposure occurred at local level and measures have been implemented to eliminate the source of infection including the removal of the suspected food item, which was not distributed outside the venue. However, given the ranging incubation period of botulism—up to eight days—and that not all customers of the restaurant in Bordeaux may have been identified despite efforts, further cases linked to this event may still occur. This outbreak has occurred at the same time as the Rugby World Cup held from the week of 4 September 2023 attracting followers and rugby teams from all over the world. 

Due to the incubation period up to eight days and the restaurant attracting international visitors, there is a possibility that additional cases among international visitors may be reported either from France or outside of France until 18 September.

Conagra Brands, Inc., a Fort Madison, Iowa establishment, is recalling approximately 2,581,816 pounds of canned meat and poultry products due to a packaging defect that may cause the products to become contaminated without showing any outward signs of contamination, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The meat and poultry products were produced between December 12, 2022, and January 13, 2023. The following products are subject to recall: [view spreadsheet] [view labels].

The products subject to recall bear establishment number “P4247” on the product cans. These items were shipped to retail locations nationwide.

The problem was discovered when the establishment notified FSIS after observing spoiled and/or leaking cans from multiple production dates at the establishment’s warehouse.

Subsequent investigation by the establishment determined that the cans subject to recall may have been damaged in a manner that is not readily apparent to consumers, which may allow foodborne pathogens to enter the cans.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  

FSIS is concerned that some product may be on retail shelves or in consumers’ pantries. Consumers who have purchased these products are urged not to consume them.

Kawasho Foods USA Inc. of New York, NY, is announcing an expansion of its February 26, 2023, voluntary recall of canned GEISHA Medium Shrimp 4oz. to now recall all lots of this product. Kawasho Foods is taking this step out of an abundance of caution due to a concern that there is a possibility that the product has been under processed, which could lead to the potential for spoilage organisms or pathogens.

Kawasho Foods made this decision after receiving additional information from the Food and Drug Administration.

The Product was distributed to retailers nationwide (AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI) from Dec 2022 to Apr 2023.

The GEISHA Medium Shrimp is packaged in a 4oz. metal can, with UPC 071140003909 (Listed on the back of the label).

This event only affects this specific product.

Consumers should not use this product, even if it does not look or smell spoiled. No illnesses or other adverse consequences have been reported to date in connection with this product.

The Michigan Department of Agriculture and Rural Development has recalled lemonade and gel products sold by Royalty Sea Moss.

After a complaint from the Maryland Department of Health, an investigation found that Royalty Sea Moss, based out of Mt. Pleasant, MI, produced products with inadequate processing controls that are needed to stop the growth of foodborne pathogens, according to the department. 

Royalty Sea Moss also does not have a license to manufacture, hold or sell products, which is a violation against the Michigan Food Law of 2000, officials said.

The following are products noted by the department for having inadequate labeling, including ingredient statements, lot codes and sell-by dates:

Regular Sea Moss Gel

Fruit Flavored Sea Moss Gel:

  • Mixed Berry with Blueberry Strawberry Raspberry
  • Pineapple Cherry Strawberry
  • Peach Strawberry Flavor
  • Strawberry Dragon fruit
  • Mango Pineapple
  • Strawberry Banana

Sea Moss Lemonade:

  • Blue Raspberry
  • Mango
  • Lemonade
  • Watermelon
  • Strawberry Peach
  • Green Apple
  • Pink Strawberry
  • Strawberry Lemonade
  • Grape
  • Pineapple
  • Strawberry Kiwi
  • Cherry
  • Fruit Punch

Improperly processed food and drink has the chance to be contaminated with clostridium botulinum, an odorless bacteria which can cause life-threatening illness or even death, according to the department.

No illnesses have been reported, but consumers are warned not to use the product, even if it doesn’t look or smell spoiled, according to the department.

Marietta, GA, September 29, 2022 – The Chai Box announced a recall of 16 oz glass bottles Chai Concentrate Mix, UPC 7 93611 81925 2 and 64 oz plastic bottles of Chai Concentrate Mix UPC 7 93611 81926 9 and 16 oz glass bottles Unsweetened Chai Concentrate Mix, UPC 793611819252 and 64 oz plastic bottles of Unsweetened Chai Concentrate Mix UPC 793611819269 due to potential under-processing which may lead to Clostridium botulinum contamination. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed. No other production codes or products are affected by this recall.

It is important to note that there have been no reports of illness associated with this product to date.

The products subject to recall are 16 oz glass bottles and 64 oz plastic bottles with Best By dates between 09/22/2022 and 03/16/2023. Please see that attached photos for ease of identification of the products.

We were notified of the problem during a process review by the Georgia Department of Agriculture. The products were shipped nationwide to consumers, retailers and wholesalers. Some product was also shipped to two consumers in Canada. Product is available online and via retail and wholesale facilities.

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King’s Hawaiian is voluntarily recalling its Pretzel Slider Buns, Pretzel Hamburger Buns and Pretzel Bites products out of an abundance of caution following a recall of an ingredient used in the pretzel products from one of its suppliers, Lyons Magnus. Lyons Magnus is recalling this ingredient due to the potential for it to cause microbial contamination including from the organisms Cronobacter sakazakii and Clostridium botulinum. While no illnesses associated with King’s Hawaiian pretzel bread have been reported, and no pathogens have been found in any King’s Hawaiian products to date, the recall is being conducted to ensure consumer safety.

This recall does not impact any other King’s Hawaiian products, as no other products use this ingredient from Lyons Magnus. King’s Hawaiian will resume producing all pretzel products once the company has ensured all current product has been disposed of and has confirmed the safety of all ingredients.

Consumers in possession of any King’s Hawaiian Pretzel Slider Buns, King’s Hawaiian Pretzel Hamburger Buns or King’s Hawaiian Pretzel Bites should dispose of the product. Consumers can contact King’s Hawaiian at 877-695-4227, Monday through Friday from 8:30 a.m. to 5:00 p.m. PT, if they have any questions, or to request replacement product.

King’s Hawaiian advises that consumers in possession of any King’s Hawaiian Pretzel Slider Buns, King’s Hawaiian Pretzel Hamburger Buns or King’s Hawaiian Pretzel Bites should dispose of the product.

This past weekend, a Grays Harbor County man aged 55-65 passed away from a probable cause of botulism. No further information on the deceased is available. Confirmation of the cause of death is pending confirmatory test results.

Grays Harbor County Environmental Health assisted the property owner with the safe disposal of around 170 pint-sized jars of home-canned food and canning jars per CDC guidelines.

Botulism is odorless and cannot be seen or tasted; however, even a small taste of food containing the toxin can be deadly, according to the CDC.

The CDC stresses that home canning, while a fun and productive way to preserve everything from seafood to vegetables, can put people at risk of botulism if not done correctly.

Using proper canning techniques, the right kind of equipment, and disposing of any canned foods that may not have been properly preserved is the best way to keep your home canned goods safe.

Two excellent resources for safe canning practices include the CDC – https://www.cdc.gov/foodsafety/communication/home-canning-and-botulism.html – and Washington State University Extension Grays Harbor – https://extension.wsu.edu/graysharbor/family/food/.

If you’re new to canning or need a refresher, the USDA has a great resource, the Complete Guide to Home Canning, available for free download at https://nchfp.uga.edu/publications/usda/GUIDE01_HomeCan_rev0715.pdf.

Soul Cedar Farm of Quilcene, WA is voluntarily recalling all batches of shelf-stable Zesty Sweet Peppers because it has the potential to be contaminated with Clostridium botulinum toxin, which can cause life- threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms.

Anyone experiencing these symptoms should immediately contact a health care provider. At this time, there are no known illnesses associated with the recalled product.

The recall was initiated after routine sampling conducted by the Washington State Department of Agriculture (WSDA) revealed that one batch of Zesty Sweet Peppers had a pH level high enough to support formation of the Clostridium botulinum toxin. Soul Cedar Farm and WSDA continue to work jointly to address the source of the problem.

The recalled product was packaged in 8-ounce glass containers and was sold at retail stores in Quilcene and Port Townsend, WA.