SILVER SPRING, Md. (FDA) — The U.S. Food and Drug Administration  warns consumers that it has tested and found milk protein in 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A.” Milk is a major food allergen, but it is not declared as an ingredient on the label. People who have a milk allergy or a severe sensitivity to milk may have a serious or life threatening reaction if they eat the product. Simply Natural Foods of Commack, N.Y., has agreed to recall the 3-ounce Simply Lite chocolate bars from these lots.
What is the Problem and What is Being Done about the Problem?
FDA testing found milk protein, a major food allergen, in 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A.” Milk is not declared as an ingredient on the label. FDA tests of samples taken from these two lots found more than 3,500 parts per million of milk protein in single 3-ounce bars of the chocolate, which is equivalent to the amount found in about 4 teaspoons of whole milk. Although the product label bears the advisory statement “may contain traces of milk,” the amount of milk protein found in the samples of this product is not what the scientific community and consumers may regard as trace amounts. Simply Natural Foods has agreed to recall the two lots.
What are the Symptoms of Illness/Injury?
Food allergy symptoms typically appear within minutes or develop up to two hours after a person has eaten the food to which they are allergic. Allergic reactions range from mild symptoms to a life-threatening whole-body allergic reaction called anaphylaxis. Symptoms can include hives; flushed skin or rash; tingling or itchy sensation in the mouth; face, tongue, or lip swelling; vomiting; diarrhea; abdominal cramps; coughing or wheezing; dizziness or lightheadedness; swelling of the throat and vocal cords; difficulty breathing; and a drop in blood pressure.
Who is at Risk?
People who have a milk allergy or a severe sensitivity to milk may be at risk of a serious or life threatening allergic reaction if they eat products containing milk.
What do Consumers Need to Do?
People who are allergic to milk or have a severe sensitivity to milk should not eat Simply Lite chocolate bars from either of these lots.
What Does the Product Look Like?
The product is packaged in a brown plastic wrapper and labeled as Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate 3-ounce bars bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A” on the back of the packaging. These are the only lots tested by the FDA and the only lots that the FDA has found to contain milk protein.
Photos of the product can be viewed on the FDA’s Flickr Photostream  .
Where is it Distributed?
The product was distributed to retail stores and markets in Calif., Fla., Ga., Ind., Nev., Mass., N.C., N.J., N.Y., Pa., Va., Wash., and Canada.
Who Should be Contacted?
The FDA asks consumers to report any adverse reactions from eating the product to an FDA Consumer Complaint Coordinator . Consumers with questions about food safety can contact the FDA at 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern Daylight Time.
Consumers can also contact Simply Natural Foods at 631-543-9600.
For more information:
Food Allergies: What You Need to Know 
Alergias a los alimentos Lo que usted debe saber 
Food Allergen Labeling and Consumer Protection Act of 2004: Questions and Answers 
The information in this news release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The FDA is warning consumers that it has found milk protein in some 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate. Milk is not declared as an ingredient on the label. Simply Natural Foods has agreed to recall these products.