Recent Product Recalls
Recent food recalls involved undeclared ingredients, potential
microbial and fungal contamination, misbranding, and inadequate
pasteurization or inspection, among others.
Undeclared allergens continue to be a major reason behind food
recalls, with more than a dozen manufacturers recalling products
for this reason in the last six weeks. According to FDA's
website, manufacturers and grocery stores recalled products because
of undeclared nuts, milk, soy, wheat, sulfites, fish, and egg in a
range of products including desserts, raisins, bagels, cheese
sticks, and pasta salad. One such product also contained undeclared
certified colors (yellow #5 and yellow #6).
Several other products, including cheese enchiladas, brown rice
flour, nuts, cheese, soybean sprouts, and smoked salmon were
recalled due to potential Salmonella or Listeria
contamination. Additionally, a creamery recalled its yogurt for
potential inadequate pasteurization, and a grocery chain recalled
organic raw almonds for possible elevated levels of naturally
occurring hydrogen cyanide.
A dietary supplement powder was recalled for containing a fungus,
and another dietary supplement was recalled for being an unapproved
new drug. FDA also posted a recall of pet food for insufficient
vitamin levels and excess minerals.
USDA recalls included pork belly product for lack of border
inspection and ground beef due potential E. coli
contamination. USDA also posted recalls of various pork products,
pretzel dog products, and pierogi products due to misbranding and
undeclared allergens.
View a complete list of product recalls for FDA-regulated products and USDA-regulated products.
Recent Warning Letters
Since we last reported on enforcement actions in October, FDA
posted warning letters addressed to canned food processors, seafood
processors, shell egg production facilities, infant formula
producers, dairies, dietary supplement manufacturers, and other
food companies for violations related to CGMP (current good
manufacturing practice), commodity-specific regulations, labeling,
illegal drug residues, and unapproved drug claims, among
others.
FDA warned four food manufacturing facilities for various CGMP
violations, including packaging food in insanitary conditions and
failure to provide adequate screening against pests. Five canned
food processors, one located in Korea and one in India, were warned
for various violations of the Acidified Foods, Low-Acid Canned
Foods, and Emergency Permit regulations. Thirteen seafood
processing facilities, including six overseas, were cited for
failing to comply with hazard analysis and critical control points
regulations. One of these companies was also found to have CGMP
violations for, among other violations, failure to monitor
prevention of cross-contamination from insanitary objects. FDA
cited one shell egg production facility for violations of the
Salmonella prevention regulations. FDA also warned nine
dairy farms for selling cattle for slaughter adulterated with
illegal drug residue.
FDA continues to review product labels for incorrect or incomplete
claims. In recent warning letters, the agency cited two cheese
manufacturers, one overseas, for various violations, including
failure to declare egg as a major food allergen, failure to
translate required nutrition information in English, and failure to
use the common or usual name of each ingredient. A Spanish
manufacturer of a dried tuna product was warned for incorrect
serving sizes and other label deficiencies. An infant formula
manufacturer was cited because its label and website bore health
claims not authorized by FDA. An ice cream manufacturer was cited
for using unsafe color additives and other labeling violations,
such as failing to state that the product contains artificial
coloring or chemical preservatives.
FDA also posted more than a dozen warning letters to dietary
supplement manufacturers. FDA warned 15 dietary supplement
manufacturers for marketing unapproved drugs because their products
promote therapeutic claims, six of which were also cited for CGMP
violations. Notably, two of the 15 warning letters were issued
jointly by FDA and FTC for marketing supplements and other products
for the purposes of preventing or treating the Ebola virus. Such
claims make the products unapproved drugs, sold in violation of the
FDCA, and also lack adequate substantiation, in violation of the
fair advertising provisions of the Federal Trade Commission Act.
Several of the warning letters note these products were advertised
on various social media sites, including Facebook. An additional
four dietary supplement manufacturers were warned for CGMP
violations; some of the manufacturers were also warned for failing
to label their products as "dietary supplements."
Lastly, in a rare warning letter to a cosmetics manufacturer, FDA
warned a skin care products manufacturer for making therapeutic
claims on its website, which renders the products unapproved new
drugs.
View FDA's Warning Letters Home page (scroll
down for listing of recently posted Warning Letters).
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