June 23, 2024 – June 30, 2024 – 12 Recalls ( 11 FDA, 1 USDA)

Industries: Gummies, Nuts, Produce, Drugs, Bakery, Confections, Fish, Pasta, Dairy, Eggs

Current FDA & USDA Recall Trends

FDA

Recalls / Contributing Factor(s)

  • 6/28/24 – Food & Beverage – Infused Cones, Chocolate Bars, and Gummies – Toxic levels of muscimol.
    • “To date, Prophet Premium Blends received two (2) complaints (on May 27, 2024), regarding consumers becoming ill after consuming the entire chocolate bar. Upon receiving the complaints, we reviewed the products’ Certificates of Analysis (COAs) which showed higher than normal amounts of Muscimol. Prophet Premium Blends initiated this Recall and has ceased the production and distribution of the Diamond Shruumz product line as the FDA and Prophet Premium Blends continues their investigation as to what is the cause of the serious adverse effects.” 1
  • 6/28/24 – Food & Beverage – Macadamia in the Raw – Potential Salmonella contamination.
    • “The potential contamination of Salmonella was discovered through the State of New York Department of Agriculture and Markets Food Laboratory through routine testing. The company is recalling this product as FDA and Sunco and Frenchie LLC continue their investigation.” 2
  • 6/27/24 – Food & Beverage – Spinach and salad mixes – Potential Listeria monocytogenes contamination.
    • “The contamination was discovered after sampling by New York State Department of Agriculture and Market Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of monocytogenes in a 9-ounce package of Bogopa “Fresh Spinach.” Production of the product has been suspended.” 3
  • 6/26/24 – Drugs – Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count – Failed dissolution.
    • Risk Statement: The failed dissolution of potassium chloride extended-release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.” 4
  • 6/26/24 – Food & Beverage – Chocolate Chip Muffin 4 count – Undeclared Walnut allergen.
    • “The recall was initiated after it was discovered that the walnut-containing product was distributed in packaging that did not reveal the presence of walnut. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.” 5
  • 6/25/24 – Food & Beverage – Chocolate-covered cocoa nibs, 4 oz – Undeclared hazelnut allergen.
    • “The recall was initiated after it was discovered that product containing hazelnuts was distributed in Chocolate-Covered Cocoa Nibs packaging that did not reveal the presence of this allergen. This issue was isolated to a single lot. No other lot codes, Feve Artisan Chocolatier, or Dandelion Chocolate products are included in this action. No illnesses have been reported.” 6
  • 6/25/24 – Food & Beverage – Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count – Failed dissolution.
    • Risk Statement: The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.” 7
  • 6/25/24 – Food & Beverage – Smoked Norwegian Salmon Slices – Toast sized, 8.1 oz – Listeria monocytogenes contamination.
    • “Routine testing has revealed the presence of Listeria monocytogenes in the specified lot 412. Listeria monocytogenes is a type of bacteria that can cause listeriosis. Symptoms vary depending on the severity of the illness, symptoms may last from days to several weeks. Mild symptoms may include a fever, muscle aches, nausea, vomiting, and diarrhea. If the more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions. Some people are more vulnerable to listeria infections, including older people, pregnant women and their unborn babies, babies less than one month old and people with weakened immune systems.” 8
  • 6/24/24 -= Food & Beverage – Deluxe Roasted & Salted Mixed Nuts – Undeclared Peanut.
    • “The recall was initiated after a consumer contacted DSD merchandisers, LLC through our website to report they purchased product and upon consuming noticed that the product contained peanut which they then noted the label did not note Peanut on the Ingredient Statement nor the Allergen Statement portion of the label the label just contained a packed on same equipment as product containing peanut statement. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s formulation change processes and packaging label change process.” 9
  • 6/24/24 – Food & Beverage – Dried Orzo and Dried Campanelle – Potential to be contaminated with mold.
    • “We initiated this recall because the product was under-dried and we found three packages within our retail marketplace that had the beginning signs of mold.” 10
  • 6/24/24 – Food & Beverage – Ice Cream Products – Listeria monocytogenes.
    • “Totally Cool, Inc. has ceased the production and distribution of the affected products due to FDA sampling which discovered the presence of Listeria monocytogenes. The company continues its investigation and is taking preventive actions. No other products produced by Totally Cool, Inc. are impacted by this recall.” 11

USDA

  • 6/30/24 – Food – Liquid Egg Products – due to misbranding and Undeclared Allergens.
    • “The problem was discovered during a routine carton inventory evaluation. The establishment notified FSIS when it discovered that a limited amount of Whole Egg with Citric Acid cartons was unaccounted for, and there was a corresponding excess of Breakfast Blend Scrambled Egg carton in inventory. The establishment investigated and determined that the unaccounted Whole Egg with Citric Acid cartons were inadvertently utilized during a single short Breakfast Blend Scrambled Egg production run. The Breakfast Blend formulation contains an allergen, a dairy ingredient (milk), which is not declared on the Whole Egg with Citric Acid label.” 12

References:

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prophet-premium-blends-recalls-diamond-shruumz-products-because-possible-health-risk

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunco-frenchie-llc-recalls-terrafina-brand-macadamia-raw-because-possible-health-risk

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/solata-foods-recalls-fresh-spinach-and-spinach-products-due-possible-health-risk

4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-behalf-bluepoint-laboratories-issues-voluntary-nationwide-recall-potassium

5 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

6 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/feve-artisan-chocolatier-and-dandelion-chocolate-issue-allergy-alert-undeclared-hazelnuts-chocolate

7 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-issues-voluntary-nationwide-recall-potassium-chloride-extended

8 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/foppen-seafood-issues-recall-smoked-norwegian-salmon-slices-81oz-toast-sized-sold-kroger-and-payless

9 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dsd-merchandisers-llc-announces-voluntary-recall-deluxe-roasted-salted-mixed-nuts-due-undeclared

10 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wildly-beloved-foods-recalling-orzo-vegan-dried-and-campbell-vegan-dried-due-potential-mold

11 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/totally-cool-inc-recalls-all-ice-cream-products-because-possible-health-risk

12 https://www.fsis.usda.gov/recalls-alerts/michael-foods-inc–recalls-fair-meadow-foundations-liquid-egg-products-due

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