Chocolate Recalls That Affected Millions
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Rich in flavor and smooth, velvety in texture, chocolate is an indulgence that most of us would be reluctant to give up. Over the years, the melt-in-the-mouth treat has evolved beyond the traditional chocolate bar or chocolate cake, making an appearance in pastries and even savory dishes. As such, it's not surprising that the ubiquitous indulgence can be found on most supermarket shelves.
Most shoppers assume that the products — including chocolate — they purchase at their local grocery store undergo proper quality checks and are safe for consumption. Unfortunately, things are not always as they seem. While the U.S. Food and Drug Administration (FDA) is doing its best to control the quality of the products that hit the market, issues with product safety still exist. In fact, the number of food recalls has increased by 15% between 2020 and 2024, as reported by Traceone. In the case of chocolate, most recalls are issued due to undeclared allergens, mislabeling, and contamination.
Interested in finding out more about recent chocolate recalls that have left their mark on the industry? Take a look at our list of chocolate recalls that impacted countless consumers.
Read more: 10 Milk Chocolate Bars, Ranked By Taste And Texture
In January 2025, the FDA upgraded the recall of three Cal Yee Farm chocolate products to the highest risk level classification — Class I. The first recall notice for the products was issued by the agency in December 2024 citing misleading labeling. Cal Yee Farm began the voluntary recall of the products on 12 December across the eight states where they had been shipped. As of February 1, no illnesses had been linked to the mislabeling, but the consequences could have been dire, potentially putting countless people at risk.
The affected products included the brand's Dark Chocolate Almonds, Dark Chocolate Apricots, and Dark Chocolate Walnuts. All the products contained milk, which wasn't declared on the packaging. The FDA recognizes milk as one of its "nine major food allergens," which can lead to a whole host of health issues including hives, cramps, and loss of consciousness. Given the severity of the allergic reaction risks, it's not surprising that the FDA ended up giving the items a Class I recall classification, indicating that coming into contact with, or consuming, the chocolates could result in "serious adverse health consequences or death."
The other Cal Yee Farm chocolate products included in the 12 December recall — but not upgraded to Class 1 — contained undeclared allergens including soy, almonds, sesame, wheat, and FD&C #6 food coloring. The products containing soy and wheat were already given a Class 1 status in December.
Founded in 1920, Hammond's Candies made its debut with Carl's Piggy Backs, bite-sized chocolate treats topped with shredded coconut. Over the years, the company has expanded its product range to include other sweets like candy canes, flavored marshmallows, and lollipops.
In 2024, Hammond's Candies recalled its Dark Chocolate Filled Mini Waffle Cones due to concerns about potential allergic reactions caused by the milk in the confectionery — a product that wasn't listed on the packaging. The safety recall was launched after a consumer suffered an adverse reaction after eating the mini waffles.
The chocolate-filled cones, which had been sold in 38 states, were given a Class II risk rating by the FDA, where the "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences." The chocolate waffles seem to have fallen short of a Class I level warning due their relatively small milk content. While the labeling on the confectionery's packaging stated that it was merely "packaged in a facility that processes egg, milk, mustard, peanuts, sesame, soy, sulfites, tree nuts, wheat," testing revealed that the product contained quantities of milk that exceeded trace amounts. The exact source of the contamination remains unknown.
Kellogg is a household name that has withstood the test of time. Mainly recognized for its cereals and snack products, the brand has been feeding families since its founding in 1906. Perhaps Kellogg's most famous product, corn flakes were invented even before the company existed in 1894. The venture's long standing legacy hasn't prevented the breakfast snack company from mishaps. In fact, over the years, Kellogg's has had to deal with numerous product recalls.
In 2024, Kellanova, formerly the Kellogg Company, voluntarily recalled its Kellogg's Corn Flakes Chocolate Flavor in the U.K. due to a "quality defect." The move came after a consumer discovered hard lumps in the cereal. According to Kellanova's press release, the lumps didn't break down with milk, creating a choking risk and the potential to damage teeth. A spokesperson for the company explained the move at the time, saying, "It's important to say that the risk of injury from these hard lumps of chocolate cereal is minimal but we're not willing to compromise on quality or safety."
Clasen Quality Chocolate specializes in producing chocolate and coatings made from sustainably-sourced cocoa beans for manufacturers and retailers. In May 2024, the company recalled over 4 million pounds of chocolate products, which had been distributed across nine states. The recall affected 10 different milk chocolate confectionery products, including Snow White Chocolate, Milk Chocolate Flavored Confectionery Drop, and White Chocolate Wafer.
All of the chocolate products were recalled due to potential contamination with salmonella. While no further details about the cause of the contamination have been provided, the recall was given a Class II rating by the FDA, meaning that it posed a moderate health risk. None of the affected products were ever linked to any cases of salmonella, which normally cause symptoms such as abdominal cramps, diarrhea, and fever. The effects of salmonella can range from mild discomfort to severe gastrointestinal issues that require hospitalization.
While Nestlé's roots can be traced back to the foundation of the Anglo-Swiss Condensed Milk Company in 1866, the company only started selling chocolate as the Nestlé & Anglo-Swiss Milk Company in the early 20th century. Today, the corporate giant's portfolio spans over 2,000 brands, including cereal, coffee, and even pet care products. Its chocolate and confectionery brands include big names like Kit Kat and Milkybar. Despite its imposing size, Nestlé hasn't escaped controversy, including instances of product recalls.
Nestlé's Toll House Chocolate Chip Cookie Dough has been hit with not just one but two separate recalls. In August 2023, the company announced a voluntary recall of the product after a number of customers found wood chips inside the dough. The recalled batches were produced on April 24 and 25, 2023. Luckily, nobody seems to have been affected by the blunder.
Significantly, Nestlé's Toll House Chocolate Chip Cookie Dough was a subject of a prior safety recall in 2009, albeit for a completely different reason — an E.coli contamination. At the time, it was reported that over 75 people in 30 states became sick after eating the product. Fortunately, no deaths were reported. While the cause of the contamination remains unknown, it's suspected that the flour in the product was the culprit behind the outbreak. At the end of the day, Nestlé recalled 3.6 million packages of the chocolate chip dough.
When Hendrik Meijer opened the doors to his first grocery store, little did he know that nine decades later the company he started would grow to 500 locations. Aside from operating as a supermarket chain, Meijer also develops its own products under a range of brand names. In 2023, the corporate giant had to recall two of its chocolate products after discovering that they might contain milk — an ingredient that was not declared on the packaging.
Both Frederik's Dark Chocolate Almonds and Meijer Express Go Cup Dark Chocolate Almonds were pulled from shelves after concerns about the allergen were raised. The recall affected products sold at Meijer and Meijer Express stores in Wisconsin, Michigan, Kentucky, Indiana, and Illinois. The grocery store chain attributed the mishap to miscommunication with its supplier, Lamontagne Chocolate Corp., about an update in one of its product specifications. No illnesses caused by the consumption of the products were reported at the time.
Featuring a network of dairies and distribution centers across the Midwest, Hiland Dairy supplies consumers with a range of dairy products, from creamy butters and cheeses to coffee creamers and ice cream. These offerings also include unflavored and flavored milk. Unfortunately, in 2021, Hiland Dairy found itself in hot water after its 1% Low Fat Chocolate Milk was found to contain food-grade sanitizers.
The recall of 240,000 ½ pint cartons of the chocolate milk units affected Texas and Oklahoma. In a press release issued by Hiland Dairy at the time, the company stated that the contamination was caused by "an employee not adhering to [company] protocols." The milk was exposed to an Ecolab product called Synergex, a no-rinse antimicrobial used to clean dairy processing equipment.
Shockingly, Hiland Dairy committed the same blunder in 2023. At the beginning of the year, the company voluntarily recalled over 300,000 cartons of Hiland Fat Free Chocolate Milk Vitamin A&D Naturally Flavored Half Pint due to the potential presence of food-grade sanitizer.
Owned by the third generation of the Ferrero family, Ferrero was founded in 1946 in Alba, Italy, as a small pastry shop. Close to eight decades later, the company is the name behind popular brands like Kinder, Ferrero Rocher, Nutella, and Tic Tac, which are sold in over 170 countries.
Even for successful conglomerates like the Ferrero Group, things don't always go according to plan. In April 2022, Ferrero had to remove two of its chocolate products from the stores. Both Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats Basket were found to be contaminated with salmonella. The harmful organism can cause abdominal pain, vomiting, diarrhea, and in the most severe cases even death. The recall was expanded the following month to include other Ferrero chocolate products, including Kinder Surprise and Kinder Mini Eggs.
The confectionery was voluntarily recalled after salmonella was found at the Arlon production site in Belgium where they were manufactured. While no cases of the illness were detected in the U.S., this wasn't the case in Europe, where consumers who had eaten products manufactured at the same site had contracted salmonella.
One of America's first chocolate companies, the story of Thompson chocolates dates back to 1879, when William H. Thompson opened his first confectionery store. In 1934, Thompson's son, Charles, rebranded the business as the Thompson Candy Company, focusing on hand-molded chocolate products. The chocolate company has grown from strength to strength and today produces over 2 million pounds of chocolate per year.
In 2021, Thompson's initiated a voluntary recall of See's Candies, including the chocolate sitting bunny and gold foil balls. While the connection between the two chocolate producers isn't clear, we can only assume that Thompson may have been a supplier or manufacturer for See's Candies at the time. Very little detail is publicly available about the incident, however, we do know that the Thompson Candy Company recalled 50,000 pounds of chocolate due to concerns about potential contamination with salmonella, a type of bacteria that can lead to severe food poisoning.
Founded in Germany in 1961, Aldi is known for its low prices, no-frills shopping, and brand products. The grocery store opened its first U.S. location in Iowa in 1976 and since then has expanded its footprint to almost 2,500 outlets around the country. Among Aldi's countless private brands is Choceur, a chocolate line that offers a range of confectionery, including assorted Belgian chocolates, chocolate eggs, and chocolate-coated nuts.
One of Aldi's sweets is the Choceur Dark Chocolate Bar, a confection the company voluntarily pulled off the shelves back in 2017. The recall was initiated after an Aldi employee found small fragments of almonds in the chocolate. Since the nuts weren't listed on the packaging, the discovery created a potential concern for those with allergies. At that stage, Aldi's Choceur Dark Chocolate Bar had already been distributed to stores across 25 states. As of 29 December, 2017, no consumers had been adversely affected due to eating the product.
Blending chocolate, caramel, and nougat, Mars Chocolate Bars were invented in 1932 in Slough, England. While the first Mars bars were handmade, today the company relies on automated machinery to make close to three million Mars bars per day. While the chocolate bars may be its most famous offering, Mars, Incorporated is also the mastermind behind a range of other popular chocolate products, including Snickers, Milky Way, and Twix.
In 2016, Mars, Incorporated made the decision to recall some of its chocolate products in 55 countries — a move that likely set the company back tens of millions of dollars. The recall took place after a consumer in Germany discovered a piece of plastic in their Snickers bar. Upon further investigation, it was determined that the offending piece of plastic came from a factory in Veghel, Holland, where it must have broken off from a protective casing during the manufacturing process.
The goods in question included the brand's most famous offerings like Snickers, Mars, and Milky Way, as well as lesser known confectionery like Celebrations and Mini Mix. A spokeswoman for Mars Netherlands explained the scale of the recall in an interview with The Guardian, saying, "We cannot be sure that this plastic was only in that particular Snickers. We do not want any products on the market that may not meet our quality requirements, so we decided to take them all back."
Häagen-Dazs may sound Scandinavian, but the ice cream's name means absolutely nothing. In fact, it was invented by one of the brand's founders — a Polish immigrant in New York, Reuben Mattus. Like many other big name brands, Häagen-Dazs is no longer overseen by its original owners. Instead, it has fallen into the hands of conglomerates, which, as it turns out, can still make potentially disastrous mistakes.
Unlike many other food products that are recalled due to ingredient mishaps, Nestlé pulled Häagen-Dazs Chocolate Chocolate Chip Ice Cream off the shelves in 2014 due to a completely different type of issue — mismatched packaging. More specifically, the product was recalled after it was discovered that the 14-ounce cartons labeled Häagen-Dazs Chocolate Chocolate Chip were filled with Häagen-Dazs Chocolate Peanut Butter. It goes without saying that the labeling on the package didn't identify one of the major allergens found in the ice cream — peanuts. The seriousness of the blunder was readily apparent as it could have led to life-threatening consequences for individuals with peanut allergies.
When Dagoba was founded in 2001, it was all about crafting high-quality, organic chocolate with a focus on sustainability and ethically sourced ingredients. The chocolatier was purchased by The Hershey Company in 2006 — the same year Dagoba issued a recall of its organic chocolate products. As far as we know, the two events were unrelated.
Dagoba took six of its dark chocolate products off the market after discovering that they were contaminated with high levels of lead. Reportedly, this amounted to 40,000 pounds of chocolate, or close to 5% of the company's 2005 production. The chocolate products, which were sold nationally, posed a serious health risk to consumers. Ingesting lead can result in a range of health problems, from muscular weakness to neurological damage. Consuming the substance can be particularly dangerous for pregnant women and children, as it can cause developmental delays and even damage to the central nervous system. While no specific illnesses were reported in connection to the recalled products, the real extent of the lead exposure may never be known.
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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 15, 2025-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. 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About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. 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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the Company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF) resulting in death. The cases of ALF to date have both occurred in non-ambulatory individuals with Duchenne. Sarepta extends its deepest sympathies to the affected families and care teams. Key Safety Initiatives Evaluating and Enhancing Immunosuppressive Regimen: As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. Sarepta is working to immediately convene an independent group of leading experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for ELEVIDYS. This panel will evaluate data and assess our proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel's recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. Suspending Shipments of ELEVIDYS for Non-Ambulatory Patients: Sarepta is temporarily suspending shipments of ELEVIDYS for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after ELEVIDYS infusion, along with post-treatment monitoring, remains the same. ENVISION Study Paused: Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). FDA concurs with this action. The pause will allow for the evaluation of a protocol amendment to incorporate an enhanced immunosuppressive regimen for the non-ambulatory patient cohort and incorporate any additional feedback from the FDA. Regulatory alignment is needed before screening and dosing in ENVISION may resume. ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating ELEVIDYS in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy. In the U.S., it serves as the confirmatory trial required under the FDA's accelerated approval pathway for non-ambulatory patients. 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Commitment to Long-Term Safety and Understanding Sarepta remains committed to a thorough approach and the highest standards of patient safety and scientific rigor. The event has been reported to FDA and global health authorities and will inform ongoing discussions around a potential label update to reflect the risk of severe ALF and additional immune management strategies for non-ambulatory patients. While elevated liver enzymes are a known class effect of all AAV-based gene therapies, the exact mechanism behind AAV-related liver toxicity remains unclear. Current evidence suggests it is likely driven by an adaptive immune response. The Company will provide additional updates as appropriate. Investor Conference Call Details Sarepta will be hosting a conference call and webcast to discuss this update and provide an update on the Company's business on Monday, June 16, 2025, at 8:00 am Eastern time. The event will be webcast live under the investor relations section of Sarepta's website at: and following the event a replay will be archived there for one year. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, the potential benefits of an enhanced immunosuppression regimen in dosing in non-ambulatory patients, and expected plans and milestones, including providing additional updates as appropriate and engaging with regulators on an enhanced immunosuppressive regimen for dosing in non-ambulatory patients. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.