OH Firm Recalls 'Einkorn' Products for Not Declaring Wheat Because Einkorn is Wheat

Stutzman Farms of Millersburg, Ohio is voluntarily recalling all products containing einkorn as the product labels do not declare wheat, a known allergen, on the product label. Stutzman Farms became aware of the misbranding issue after it was brought to our attention by the Ohio Department of Agriculture.

From the Einkorn.com website "Einkorn is the oldest wheat known to scientists, and is considered man’s first wheat. The term einkorn is derived from the German language and interpreted to mean “single grain”. Einkorn wheat is known in taxonomy as either Triticum boeoticum (wild wheat), or Triticum monococcum (domesticated species). Domesticated and wild forms of wheat may be considered either as separate species, or as Triticum monococcum’s subspecies."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stutzman-farms-issues-voluntary-recall-its-einkorn-products-undeclared-wheat-allergen
Stutzman Farms Issues a Voluntary Recall of its Einkorn Products for an Undeclared Wheat Allergen
Summary
Company Announcement Date:  March 08, 2022
FDA Publish Date:  March 09, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat
Company Name:  Stutzman Farms
Brand Name:  Stutzman Farms
Product Description:  Products containing einkorn: berries, flour, pretzel, more.

Abbott Expanded Recall of One Lot of Baby Formula

Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot.  Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-expands-recall-powder-formulas-manufactured-one-plant
Abbott Voluntarily Expands Recall of Powder Formulas Manufactured at One Plant
Summary
Company Announcement Date:  February 28, 2022
FDA Publish Date:  March 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport
Company Name: Abbott
Brand Name:  Similac, Alimentum, and EleCare
Product Description:  Powder Infant Formula

CA Establishment Recalls Jerky Products After USDA Sampling Finds Listeria Positive Sample

Boyd Specialties, LLC, a Colton, Calif. establishment, is recalling approximately 1,634 pounds of ready-to-eat (RTE) jerky products that may be adulterated with Listeria monocytogenes.  The problem was discovered by FSIS during follow-up procedures after a routine FSIS product sample confirmed positive for Listeria monocytogenes.

The product was packed under a variety of label brands and was shipped to retail locations in Alabama, California, Connecticut, Michigan, New Jersey, North Carolina, Pennsylvania, and Texas

Currently, the recall is limited to one day of production (Feb 23, 2022), but with recalls of this nature, it would not be surprising to see this recall expanded.

https://www.fsis.usda.gov/recalls-alerts/boyd-specialties-llc-recalls-jerky-products-due-possible-listeria-contamination
Boyd Specialties, LLC Recalls Jerky Products Due to Possible Listeria Contamination
BOYD SPECIALTIES LLC

FSIS Announcement

WASHINGTON, March 4, 2022 – Boyd Specialties, LLC, a Colton, Calif. establishment, is recalling approximately 1,634 pounds of ready-to-eat (RTE) jerky products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FDA Releases Final Guidance for Conducting A Voluntary Recall

FDA released its finalized guidance for conducting a voluntary recall.  The document, "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C", was issued as a draft in 2019.   It discusses the various elements of a recall including having a recall plan, conducting training, maintaining records, and interacting with the FDA.  There were some minor changes from the draft including adding terminology, including the term "market withdrawals".

It would be worthwhile downloading this document and reviewing it against your current recall plan.

FDA Guidance
Guidance--Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (fda.gov)
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff

INTRODUCTION

The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff 
regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead  to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR part 1240. This guidance applies to devices that are electronic products regulated as radiology devices subject to 21 CFR part 892. It does not apply to electronic products subject to 21 CFR parts 1003 and 1004. 

MO Company Recalls Beef Sticks After Recognition The Gluten Free Declaration Wrong Because Product Contains Wheat

Frickenschmidt Foods LLC, a Lockwood, Mo. establishment, is recalling approximately 5,795 pounds of ready-to-eat beef stick products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains and declares wheat as an ingredient but has an incorrect statement of “gluten free” on the label. The problem was discovered when the distribution company notified the establishment that the product is labeled as “gluten free” but lists wheat in the ingredients statement.

https://www.fsis.usda.gov/recalls-alerts/frickenschmidt-foods-llc-recalls-ready-eat-beef-stick-products-due-misbranding
Frickenschmidt Foods LLC Recalls Ready-to-Eat Beef Stick Products Due to Misbranding
FRICKENSCHMIDT FOODS LLC
FSIS Announcement

WASHINGTON, Feb. 22, 2022 – Frickenschmidt Foods LLC, a Lockwood, Mo. establishment, is recalling approximately 5,795 pounds of ready-to-eat beef stick products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains and declares wheat as an ingredient but has an incorrect statement of “gluten free” on the label.

Chocolate Covered Cherries Recalled After Product Inadvertently Mixed with Almond Containing Product

Torn & Glasser of Pomona, CA is recalling 231 cases (2,772 units) of Dark Chocolate Covered Cherries due to an undeclared allergen. The Dark Chocolate Covered Cherries may also contain Dark Chocolate Almonds which are Tree Nuts (Almond) allergen.  The recall was initiated after it was discovered that product containing Dark Chocolate Covered Cherries was mixed with Dark Chocolate Covered Almonds in the bag. Subsequent investigation indicates that some Dark Chocolate Covered Almonds were used for Dark Chocolate Covered Cherries by Production personnel.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-torn-glasser-recalls-sprouts-farmer-market-dark-chocolate-covered-cherries-12-oz-because
Urgent: Torn & Glasser Recalls Sprouts Farmer Market Dark Chocolate Covered Cherries 12 Oz. Because of Undeclared Almond Allergen
Summary
Company Announcement Date:  March 04, 2022
FDA Publish Date:   March 04, 2022
Product Type:  Food & Beverages  Snack Food Item  
Reason for Announcement:  Undeclared almonds
Company Name:  Torn & Glasser
Brand Name:  Sprouts Farmers Market
Product Description:  Dark Chocolate Covered Cherries

Bakery Items Recalled After Label Printer Misses The Allergen Statement

The Third Synthesis Inc DBA Chicago Sweet Connection Bakery is issuing a voluntary recall for fresh baked Coffee Cakes (Various Flavors) and fresh baked Paczkis (Various Flavors) produced between February 21st, 2022 to February 23rd, 2022 because the label does not declare Egg, Milk, and Wheat.
The recall was initiated after it was discovered that the allergen statement was not correctly printing on labels due to a computer error. The label was being cut off before the allergen statement could print. Products produced after these dates have been corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/third-synthesis-inc-issues-allergy-aert-undeclared-egg-milk-and-wheat-allergen-statement
The Third Synthesis Inc Issues Allergy Alert on Undeclared Egg, Milk, and Wheat Allergen Statement
Summary
Company Announcement Date:  February 28, 2022
FDA Publish Date:  March 03, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared egg, wheat, milk allergen
Company Name:  Chicago Sweet Connection Baker
Brand Name:  Chicago Sweet Connection Bakery
Product Description:   Coffee cake and paczkis varieties

USDA Issues Warning for Product that Contains Unlabeled Allergen Due to Supplier Error

USDA - FSIS is issuing a public health alert for various ready-to-eat (RTE) meat products containing a FDA regulated seasoning mix that has been recalled by the producer, PS Seasoning of Iron Ridge, Wis., due to concerns that the seasoning mix may contain undeclared wheat.   The problem was discovered when the FSIS inspected establishments received notification from their seasoning supplier that the seasoning mix, which is regulated by FDA, may contain undeclared wheat. The establishments then notified FSIS of the issue. FSIS and FDA are coordinating on this issue.

This is a supplier issue with mislabeling that affects downstream producers.  This supplier should have had an Allergen Preventive Control in place to ensure proper labeling.  But as the purchaser of that product, a company should understand the need for that supplier to have such controls in place.  How would they know that there is such a need?  If a spice supplier is packing various products with different allergen groupings, they would need such controls.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-meat-products-containing-fda-regulated
FSIS Issues Public Health Alert for Ready-to-Eat Meat Products Containing FDA-Regulated Seasoning Mix That Has Been Recalled Due to Misbranding and an Undeclared Allergen

FDA Issues Warning Letter After Recall Due to Undeclared Allergen Due to Mislabeling Error

FDA issued a Warning Letter to Cedar’s Mediterranean Foods Inc. after a October 2021 recall where the company's Organic Mediterranean Hommus was labeled with the ingredient declaration for its Organic Everything Hommus in that the finished product label did not declare a major food allergen--tree nuts (i.e., Pine Nut).

The company provided FDA the reason for mistake - "stated that the root cause of the problem was that an employee failed to follow the label change over procedure and performed an unauthorized label change. The email also stated that you retrained all employees that perform labeling, took disciplinary action against the employee that performed the unauthorized change, and that you will develop a label reconciliation program."   In response FDA stated "it appears that you did not implement adequate allergen preventive controls."

The responsibility should not be on one employee, but a Preventive Control that incorporates monitoring and verification by additional employees.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cedars-mediterranean-foods-inc-623473-02112022
Cedar’s Mediterranean Foods Inc.
MARCS-CMS 623473 — FEBRUARY 11, 2022