FDA Issues a Warning Letter to CA Bakery for Being Nasty

FDA issued a Warning Letter to a CA bakery for, in short, being nasty.   They missed the memo that they had to comply with FDA regulations.  A problem we have seen with many smaller companies that are now required to have registered with FDA and thus are subject to FDA inspection...especially an issue among bakeries.

"..food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.  In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu))." 

The inspection of the company found that they...:

• Did not have a written food safety plan.
• Did not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas to protect against contamination of food on your premises by pest..had rodent excrement and insects in various places.
• Did not clean all food contact surfaces, including utensils and equipment, as frequently as necessary to protect against allergen cross-contact and against contamination
• cutting boards used to prepare products were scarred and heavily stained with a dark residue, and the plastic containers used to hold and dispense various dry ingredients were observed cracked, some being held together with blue tape,
•  ice cream scoop, used to fill lemon poppy muffins which contain almonds and wheat flour, was seen stored in a bucket of water and then used to fill gluten free muffins, which do not contain almonds or wheat flour, without being cleaned between uses
•  prepare products with raw ingredients on the same wooden table that finished products are prepared for further processing and packaging.
• The floors are not constructed in such a manner that they may be adequately cleaned and kept in good repair - specifically, during the inspection our investigators observed standing water and pitted floors with exposed aggregate, immediately adjacent to clean equipment on shelves. 
• Employees working in direct contact with food, food-contact surfaces, and food packaging materials did not conform to hygienic practices 
• Wholesale products are misbranded - the product labels fail to bear the common or usual name of the food, labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, labels fail to include the place of business of the manufacturer, packer, or distributor, and the Lemon Poppy and Strawberry Cupcake Muffin products bear or contains a color additive which is unsafe within the meaning of section

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sweet-production-inc-578494-06172019
WARNING LETTER
Sweet Production Inc.
MARCS-CMS 578494 — Jun 17, 2019

Duncan Hines Cake Mix Recalled after Outbreak Strain Found in Product

Conagra Brands is recalling Duncan Hines cake mixes after being connected "with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak", where five people have become infected.  The Salmonella strain, Salmonella Agbeni, matched the organism collected from ill persons as determined through the use of Whole Genome Sequencing.  "While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing."

The baking process, if properly followed, will eliminate the organism,  However, people do eat raw batter and there is the issue of cross contamination that can occur in the kitchen when the powder mix gets onto food contact surfaces as well as other food.

Has this been an issue in the past?  Salmonella as well as STEC E. coli have been involved in flour related outbreaks and recalls (1, 2, 3 4, 5 ).  Improved techniques for tracking outbreaks and for identifying specific organisms using Whole Genome Sequencing have given a truer look at sources that may not have identified in the past.

https://www.fda.gov/Safety/Recalls/ucm625144.htm

Duncan Hines Classic White, Classic Butter Golden, Signature Confetti and Classic Yellow Cake Mixes Recalled Due to Potential Presence of Salmonella

For Immediate Release

November 5, 2018

September is National Food Safety Education Month

September is National Food Safety Education Month.

If we get these basics down, we will go a long way to preventing foodborne illness.....

1. Wash your hands....well, with soap.

2. Handle your raw meat. poultry and seafood as though it may be contaminated...because it probably is.

3. Follow directions for cooking.....including using a thermometer.  Remember...cookie dough must be baked first, hamburgers must reach 160F (155 for professionals), etc.

4. Clean your counters and other food surfaces....with detergent and clean moistened towel, not just that nasty cloth that was lying on counter or the floor.

5. Prevent raw food from contaminating ready-to-eat foods - cover, separate, wrap

6. Refrigerate...40F or less...don't let food sit around, get it in the refrigerator.  And check to see if your refrigerator is at the right temperature.

USDA Website - National Food Safety Education Month
https://www.usda.gov/media/blog/2018/09/04/kick-national-food-safety-education-month-great-hand-washing-methods-use-all

PRWeb
https://www.prweb.com/releases/how_to_get_a_safe_meal_on_the_table_five_often_forgotten_food_safety_basics_from_the_partnership_for_food_safety_education/prweb15729014.htm
How to Get A Safe Meal on the Table: Five Often-Forgotten Food Safety Basics from the Partnership for Food Safety Education
During National Food Safety Education Month, Integrate Food Safety into the Delight of Family Dinner

This Week in Mislabeled Products - Week Ending October 13, 2018

Protein Shakes Missing Almond Flour on Label - Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.  The issue was discovered by the company.

Ice Cream Recalled After Reaction to Undeclared Peanut - Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen.  "he recall was initiated following consumer reports of an allergic reaction after consuming the product. The facility has identified corrective actions that will prevent reoccurrence."

https://www.fda.gov/Safety/Recalls/ucm623242.htm
Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake
For Immediate Release
October 11, 2018

Acorns.......the New Old Superfood?

More people are looking for that food or pill that will improve health.  Well, instead of a cache of pills or some over processed beverage drink, let's consider eating what squirrels and bears eat....acorns.

In an review article in Comprehensive Reviews in Food Science and Food Safety, researchers found that the lowly acorn is chock full of healthful stuff.  In addition to a whole host of phytochemicals, acorns are a good source of fiber, protein, and vitamins A and E, and unsaturated fatty acids.

This Week in Mislabeled Products for Week Ending April 6, 2019

Mislabeled Soup Results in Allergen Issue - Blount Fine Foods, a Fall River, Mass. establishment, is recalling an undetermined amount of ready-to-eat chicken soup products due to misbranding and an undeclared allergen, the product contains milk, a known allergen, which is not declared on the product label. The institutional, frozen “Chicken & Poblano Pepper Soup” items, which were labeled incorrectly as “Homestyle Chicken Noodle Soup,” The problem was discovered when the firm received a consumer complaint.  (Production issue  - wrong labels used when packing product...simple mistake, costly error, easy to prevent).

Crust Contains Almond Flour Which was Missed in Design of Label - Little Red Rooster Ice Cream Company, d/b/a NadaMoo! (“NadaMoo!”) announced a limited voluntary recall of approximately 26,000 pints of its Strawberry Cheesecake Non-Dairy Frozen Dessert because they contain an undeclared almond ingredient. The recall was initiated as soon as it was discovered that the pie crust inclusions in the Strawberry Cheesecake product containing almond flour as an ingredient was inadvertently filled into packaging that did not declare that ingredient, potentially exposing consumers to an undeclared allergen.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-041-2019-release
Blount Fine Foods Recalls Ready-To-Eat Chicken Soup Product due to Misbranding and an Undeclared Allergen
Class I Recall
041-2019
Health Risk: High
Apr 4, 2019

CA Processor of Fresh Noodle Product Issued Warning Letter for Everything...Close to Everything

FDA issued a Warning Letter to Lucky K.T. Co., Inc of El Monte, CA a processor of Fresh Rice Noodle and Rice Stick Noodle food product.

It is a huge Warning Letter, so in quick summary:

• Did not have a food safety plan with the required elements for any of the products manufactured at the  facility.
• Did not have proper controls in place for a cooked RTE product (w/pH > 4.6 and Aw close to 0.99) that could potentially support the growth of sporeforming pathogens such as B. cereus and C.botulinum.  Specifically time/temperature controls.
• Did not develop and implement controls for allergens or mycotoxins.
• A huge list of GMP violations were noted.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lucky-kt-co-inc-659663-01262024
WARNING LETTER

Lucky K.T. Co., Inc.
MARCS-CMS 659663 — JANUARY 26, 2024

This Week in Mislabeled Product - Week Ending 1/20/17

Misprinting of Label Leaves Off Milk - Ottogi America, Inc. of Gardena, CA is recalling 6.40 ounce “Rice cake soup” food, because it may contain undeclared milk.  The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a misprinting in the company's packaging processes.

Chicken Salad with Wrong Lid - Duke Sandwich Productions, Inc., an Easley, S.C. establishment, is recalling approximately 743 pounds of chicken salad products due to misbranding - the products were packaged with two different product names. The chicken salad was packaged in the pimento cheese container, but it had “Chicken Salad” listed on the lid.  The problem was discovered on Jan. 16, 2018, after the firm received a complaint from a retail store manager.

Chicken Salad with Wrong Label  Café Spice GCT Inc., a New Windsor, N.Y. establishment, is recalling approximately 289 pounds of chicken salad products due to misbranding and an undeclared allergen, - the chicken salad was packaged with a chicken wrap label. The chicken salad contains milk, a known allergen, which is not declared on the chicken wraps’ product labels.  The problem was discovered by a retail customer, who then notified the company. Following the company’s internal investigation, they contacted FSIS.

Almond Flour In Cheesecake Due to Supplier Error  - Nine Whole Foods Market stores in Connecticut, Massachusetts, and Rhode Island are voluntarily recalling cheesecake bars because the product potentially contained a tree nut allergen (almond flour) that was not listed on the product label. The issue was discovered by Whole Foods Market after the incorrect product was shipped by the supplier to the distributor.

Inadequate Line Cleaning - Palmer Candy Company (www.palmercandy.com), is recalling Sea Salt Caramel Hearts (that were only sold at one store in the Midwest States) due to possible peanut allergen contamination.  "The issue was discovered by Palmer Candy Team Members. During the packing process a peanut was observed stuck to the outside of the Sea Salt Caramel Heart."  This may indicate that the processing line was inadequately cleaned after a peanut production run.

Wrong Package Label - Bellisio Foods, Inc., a Jackson, Ohio, manufacturer, is voluntarily recalling certain Michelina’s Fettuccine Alfredo due to the possibility some packages may contain undeclared chicken with soy that is not listed on packaging.  This recall was issued on 12/22/17, but FDA issued this report this week.  While details are limited, one would guess this was a packaging error when the Alfredo was placed on a chicken and soy containing product.

https://www.fda.gov/Safety/Recalls/ucm592996.htm

Ottogi America, Inc. Issues Allergy Alert on Undeclared Milk in Rice Cake Soup

For Immediate Release

January 19, 2018

FDA Warning Letter Issued to Kansas Bakery for Significant GMP Issues

FDA issued a Warning Letter to a Kansas Bakery after an extended inspection in August of 2021.  The company had not issued a response to the observations that were noted on the  Inspection Form 483.

There are a number of issues cited under each of these items.
Item 1 - Lots of bugs including cockroaches and flies.
Item 2 - Really dirty equipment

Item 3 - Poor employee practices when working with RTE foods

Looking at the facility on Google Street View, it is hard to believe that FDA was able to find this shack-like building.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bakery-project-inc-dba-delano-bakery-617718-01042022
Bakery Project Inc. dba Delano Bakery
MARCS-CMS 617718 — JANUARY 04, 2022

FDA Warning Letter Issued to NE Candy Company, Company Up for Auction

FDA issued a warning letter to New England Confectionary Company, or NECCO, the maker of Sweethearts, NECCO Wafers, and Mary Jane candies.

A basic summary of the findings:

• Excessive / uncontrolled rodent activity throughout facility
• Leaks in facility from duct work occurring in areas where product is processed
• Improper cleaning of equipment resulting in residuals being left on equipment and utencils
• Inadequate cleaning of non-food surfaces
• Improperly maintained or constructed equipment that creates un-cleanable conditions

From the letter, the company had an opportunity to improve after initial inspections, and the Warning Letter was sent after inadequate response.

It seems that NECCO had filed for bankruptcy protection and  was going up for auction.  Not sure if the mice are placing a bid.

FDA WARNING LETTER
CMS # 545899
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
May 16, 2018

FDA Warning Letter Issued to Bakery for Lack of Allergen Preventive Controls

FDA issued a Warning Letter to a Chicago bakery, Third Synthesis Inc., dba Chicago Sweet Connections, Inc..  FDA determined that the ready-to-eat (RTE) cakes and paczkis manufactured in the facility were adulterated within the meaning of the regulation because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule. 

The facility did not consider allergens a significant hazard within the food safety plan although the "facility receives, stores, and uses allergens such as wheat, milk, egg, soy, and tree nuts (including walnuts, pecans, and coconut) in production." FDA concluded "Therefore, undeclared allergens are a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control."  Further, "Furthermore, as mentioned above, FDA investigators observed several types of paczkis and coffee cakes which did not declare allergens, including wheat, milk and/or egg."

Another issue with the Food Safety Plan was not utilizing a Sanitation Preventive Control for pathogens in post-process environment.  The report also criticizes the plan development for not identifying mycotoxins as a hazard in the hazard analysis.

There were also a number of label design issues that resulted in a number of products being mislabeled.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/third-synthesis-inc-dba-chicago-sweet-connections-inc-633453-09062022
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
MARCS-CMS 633453 — SEPTEMBER 06, 2022

Recipient:
Anthanasios Kailis
President/CEO/Owner
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago, IL 60630
United States

Wheat-free Power Pancakes Recalled for Containing 1% Wheat

Phil’s Power Pancake of Costa Mesa, CA is recalling its 5 oz. packages of individually wrapped Power Pancakes in all 5 varieties (Mango, Raspberry, Cranberry, Dates, and Chocolate Chip Hempseed) because they may contain undeclared wheat.  All 5 varieties of pancakes contain rye flour that contains 1% wheat. Labels on the product distributed state “wheat free” and new labels will read “99% wheat free”.

1) That 1% present does not allow one to say 'free' from that.

2) Power pancakes are a thing.....just have to douse them with plenty of maple syrup I guess to get them to slide on down.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/phils-power-pancake-issues-allergy-alert-undeclared-wheat-phils-power-pancake
Phil’s Power Pancake Issues Allergy Alert on Undeclared Wheat in Phil’s Power Pancake
Summary
Company Announcement Date:  November 17, 2022
FDA Publish Date:  November 18, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Phil’s Power Pancake
Brand Name:  Phil’s Power Pancake
Product Description:  Pancakes in 5 varieties (mango, raspberry, cranberry, dates, chocolate chip hempseed

NY Company Recalls Gluten Free Cookies for Containing Gluten Due to Ingredient

Sweet Loren’s of New York, NY is voluntarily recalling a single lot code of Sweet Loren’s Sugar Cookie Dough 12oz, because it may contain traces of gluten in product labeled as gluten free.   This issue was identified through testing of the product in-house. The oat flour used was determined to have traces of gluten despite having documentation (COA) declaring it to be gluten free.

Can you rely just on a COA (certificate of analysis)?  Too often, receiving an acceptable COA is the extent of a company's supplier control program.  Clearly, this ingredient needs to be addressed with a Supplier Preventive Control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sweet-lorens-inc-issues-voluntary-allergy-alert-undeclared-gluten-product
Sweet Loren’s, Inc Issues Voluntary Allergy Alert On Undeclared Gluten in Product
Summary
Company Announcement Date:  July 16, 2022
FDA Publish Date:  July 18, 2022
Product Type:  Food & Beverages  Bakery Product/Mix  
Reason for Announcement:  Undeclared gluten
Company Name:  Sweet Loren’s
Brand Name:  Sweet Loren’s
Product Description:  Sugar cookie dough

This Week in Mislabeled Product - Week Ending 6/30/2018

Milk Not Added to Label - A Boston, Mass. establishment, is recalling approximately three pounds of chicken wrap products due to misbranding and undeclared allergens - the products contain milk which is not on the label.  The problem was discovered by FSIS personnel during routine in-plant verification activities. (Label design error).

Supplier Change in Formation Not Communicated - Whole Foods Market is voluntarily recalling Whole Foods Market brand oatmeal raisin cookies from stores in eight states because the products contained soy flour that was not listed on the product label. The problem was discovered when discovered when the supplier notified the company of an unannounced ingredient change. (Supplier error).

Mislabeled Salad Dressing - Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing  after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. (Production error in labeling).


https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2018/recall-057-2018-release
L&D Market, Inc. Recalls Chicken Wrap Products Due to Misbranding and Undeclared Allergens
Class I Recall 057-2018
Health Risk: High Jun 29, 2018

Closure of Local Pizza Shop Gains Media Attention

Canyon Pizza has been a State College staple for late night pizza since 2001. Not necessary an award winning pizza, but with its large pies and cheap price, it have endured the ever changing restaurant scene in this college town. After an inspection by the local health authority this week, however, it received a lot of press, although not the good kind.

The inspection noted 13 violations.  None by itself that would store-closing, but in total, it paints the picture of a dirty operation, one that is definite need of a good scrubbing and repair.  How did it get to this point?  Didn't management look closely and think that things are not as they should be?  Why do some have to wait until an inspection in order to do the necessary work?  And now, to have the brand damaged for all to see.

PDA website for results of restaurant inspections
https://www.pafoodsafety.pa.gov/Web/Inspection/PublicInspectionSearch.aspx

4 - 301.14 Explain Code Submit
Inspector Comments
--Hood system is not adequate to remove heat and/or grease, as evidenced by condensate and/or grease collecting on the walls, ceilings, and fixtures. Hood is in need of a professional cleaning as required by the Centre Region Property Maintenance Code.

Topics in Supply and Demand - Sweet Potatoes, Chicken Strips, Bananas and Bug Flour

Trend in vegetable farming - there is a decrease in acreage planted for  sweet corn, green beans, peas and potatoes, with an increase in sweet potatoes and leafy greens such as spinach, kale and romaine lettuce.  

Chicken strips gaining on chicken nuggets - While more chicken nuggets are sold compared to chicken strips, chicken strips sales have increased against a decline in chicken nuggets.

Bananas are on the ropes, can CRISPR save them - In case you missed it, a virus is likely to make America's favorite fruit, the banana, extinct.  The hope is that scientist can modify the genetic makeup of the virus to make it resistant...otherwise, there will be no bananas, no bananas someday too soon.

Bugs as ingredients, "There is an increasing range of insect-based products, such as whole/flour, snacks, health bars, pasta, pasta sauce and burgers. Edible insects are promoted as a sustainable food alternative. It is also claimed there are numerous health benefits from eating bugs and insects."  But what strategy do purveyors take in identifying their product to attract customers?

Washington Post

Business

https://www.washingtonpost.com/business/2019/04/20/sweet-corn-out-sweet-potatoes-data-shows-fundamental-shifts-american-farming/?utm_term=.70dfc8fca246

Sweet corn out, sweet potatoes in: Data shows fundamental shifts in American farming

By Laura Reiley and Andrew Van Dam

April 20

CDC Investigate E. coli Outbreak Linked to Cake Mix

The CDC is investigating an outbreak of pathogenic E. coli, strain O121, that has been linked to cake mix. To this point, there have been 16 illness with 7 of those being hospitalized.  Sick people range in age from 2 to 73 years, with a median age of 13, and 100% are female. 

The key here....do not eat raw cookie dough.  Cookie dough must be cooked per directions.   Along with that, carefully clean up surfaces and equipment after use.  Remember that the raw flour on surfaces can be potentially contaminated.

E. coli infection is nothing to mess with.  It can lead to bloody diarrhea, high fever, and worse, can produce a toxin that is detrimental to the kidney.

CDC Investigation Notice
E. coli Outbreak Linked to Cake Mix | CDC
E. coli Outbreak Linked to Cake Mix
Posted July 28, 2021
Fast Facts
Illnesses: 16
Hospitalizations: 7
Deaths: 0
States: 12
Recall: No
Investigation status: Active

Investigation Details
July 28, 2021
CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of E. coli O121 infections linked to cake mix.

Outbreak Case Counts Increase for Daily Harvest's Lentil and Leek Crumbles, Tara Flour Identified as Cause

As last reported by FDA on 7/28/22 on a disease outbreak associated with Daily Harvest's Lentil and Leeks Crumble, there have been 329 illness events with 113 hospitalized.  The cause of the outbreak has been identified as the Tara Flour, but there is little more information than that.

Case Counts
Total Adverse Illness Events: 329*
Hospitalizations: 113*
Deaths: 0
Last illness onset: July 16, 2022*
States with Adverse Illness Events: AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, MD, MA, MN, MS, MI, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI
Product Distribution: Nationwide
*Estimate based on Consumer Complaint and CAERs reports received by the FDA


https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-adverse-event-reports-french-lentil-leek-crumbles-june-2022?utm_medium=email&utm_source=govdelivery#contact
Investigation of Adverse Event Reports: French Lentil & Leek Crumbles (June 2022)

CDC - 2018 Salmonella Outbreak Linked to Raw Cake Batter

In a 2018 Salmonella outbreak where 7 people in 5 different states become ill, raw cake mix was identified as the source.  The organism isolated from the individuals match the organism found in an unopen box of cake mix.

Of course, this means that these people ate raw cake dough.  In one case, "The Wisconsin patient reported having consumed an entire box of raw white cake mix over several days during the likely exposure period."

And what are we supposed to do with cake flour....bake it.  One can guess there are no instructions on the box for eating it raw.

https://www.cdc.gov/mmwr/volumes/68/wr/mm6834a5.htm
Notes from the Field: Multistate Outbreak of Salmonella Agbeni Associated with Consumption of Raw Cake Mix — Five States, 2018
Weekly / August 30, 2019 / 68(34);751–752

This Week in Mislabeled Products - Week ending September 22, 2018

No Allergen Declaration on Label - Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch,because it may contain undeclared milk and soy.  The recall was initiated after a routine inspection by the Texas Department of State Health Services determined that the product had been distributed without proper allergen labeling for milk and soy.

Wheat on Ingredient List but not Allergen Declaration - Lidl US has voluntarily recalled all Bellona brand “Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor” confections as a precautionary measure because the allergen statement does not include wheat.  Wheat flour is correctly listed as the second ingredient on the package, but the allergen statement does not include wheat alongside the properly declared allergens listed.

https://www.fda.gov/Safety/Recalls/ucm621293.htm
Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey
For Immediate Release
September 20, 2018