November 2023 – 11/26 – 12/2 – 12 Recalls (11 FDA, 1 USDA)

Current FDA & USDA Recall Trends

FDA

Recall / Contributing Factor(s)

  • 12/1/23 – Food & Beverage – Whole Cantaloupe – Potential to be contaminated with Salmonella.
    • “The voluntary recall is due to the FDAs ongoing investigation of an outbreak involving Malichita brand cantaloupe. The cantaloupes have the potential to be contaminated with Salmonella.” 1
  • 12/1/23 – Food & Beverage – Cantaloupe chunks and fruit mixes containing cantaloupe – Potential to be contaminated with Salmonella.
    • “Cut Fruit Express learned that their supplier is issuing a recall on Cantaloupes for potential contamination of Salmonella. Cut Fruit Express is initiating a recall on the affected product that contains the recalled Cantaloupe. The affected products were shipped between October 24th through October 26th, 2023.” 2
  • 12/1/23 – Food & Beverage – Dark Chocolate Coins – Undeclared milk.
    • “This recall was initiated after the company was notified by their Quantity Control Department that a limited number of bags labeled as “Dark Chocolate Coins” contained Milk Chocolate Coins, which contains milk allergen that is not declared on the label. All dairy Milk Chocolate Coins are wrapped in Gold Foil within a Blue Netting and all non-dairy Dark Chocolate Coins are wrapped in Silver Foil within a Red Netting.” 3
  • 11/30/23 – Food & Beverage – Fruit Cups containing cantaloupe – Potential for Salmonella contamination.
    • “The recall was initiated after a supplier notified Bix Produce that they had delivered recalled Malachita cantaloupes to Bix Produce and that those had been processed and distributed by Bix Produce.” 4
  • 11/30/23 – Medical Devices – Novum IQ syringe infusion pump – Potential for an incomplete infusion following one or more downstream occlusion alarms.
    • “Baxter has identified that after one or more downstream occlusion alarms occur on the Novum IQ syringe pump, the pump may display an “Infusion Complete” alarm despite fluid remaining in the syringe. This could lead to an underdose and/or interruption of therapy. The difference between the remaining volume to be infused displayed on the pump and the volume left in the syringe is dependent on the number of occlusion alarms encountered during an infusion and the size of the syringe being used.” 5
  • 11/30/23 – Food & Beverage – Deli sub and breakfast bagel sandwiches – Undeclared sesame.
    • “The recall was initiated after it was discovered that the sesame-containing products were distributed in packaging that did not reveal the presence of sesame. Subsequent investigation indicates the problem was caused by a breakdown in the company’s labeling process. 6
  • 11/29/23 – Dietary Supplements, Drugs – Magnum Male Sexual Enhancement XXL 9800 capsule – Undeclared Sildenafil.
    • “The products have been found to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new drug for which safety and efficacy has not been established and, therefore, subject to recall.” 7
  • 11/29/23 – Food & Beverage – Triple Chocolate Almond Flavored Whey Protein Bars – Potential presence of foreign material.
    • “Doctors Scientific Organica is initiating a voluntary recall of a limited quantity of Burn Boot Camp Afterburn Grass-Fed Whey Protein Bars (60 grams) Triple Chocolate Almond flavor products due to the potential presence of foreign material, including disposable hairnet, shrink wrap and parchment paper. Foodborne foreign objects that are flexible and not sharp may cause minor injuries such as transient choking or gastrointestinal system injury.” 8
  • 11/28/23 – Food & Beverage –Fruit cups and trays containing cantaloupe – Potential to be contaminated with Salmonella.
    • “Due to the now expanded recall of fresh, whole cantaloupes by TruFresh, Kwik Trip, Inc. is issuing this recall. Cantaloupes recalled by TruFresh were used as a raw material in Kwik Trip, Inc. fruit cup and tray products listed below.” 9
  • 11/28/23 – Food & Beverage – Pepper Jack Raw Milk Cheese – Presence of Listeria monocytogenes.
    • “The Pennsylvania Department of Agriculture warns that consumers should discard “Hilltop Meadow Farm” brand ’60 Day Aged Pepper Jack Raw Milk Cheese’ with sell by dates of 9/21/2023 or earlier. Testing of this cheese confirmed the presence of Listeria monocytogenes” 10
  • 11/27/23 – Drugs – Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL – Due to crystallization formation.
    • “Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted.” 11

USDA

  • 12/1/23 – Food – Ready-to-Eat Beef and Poultry Products – Possible Listeria Contamination.
    • “The problem was discovered when the establishement notified FSIS that its laboratory testing indicated the product may be contaminated with Listeria monocytogenes.” 12

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacific-trellis-fruit-recalls-malichita-brand-cantaloupes-due-possible-health-risk

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cut-fruit-express-recalls-fresh-cut-fruit-mix-containing-cantaloupe-because-possible-health-risk

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/manischewitz-issues-product-mislabeling-advisory-and-voluntary-recall-some-very-limited-units-their

4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bix-produce-issues-safety-alert-cut-cantaloupe-products-due-potential-salmonella-contamination

5 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-novum-iq-syringe-infusion-pump-due-potential-impact

6 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gaws-gourmet-foods-issues-allergy-alert-undeclared-sesame-sandwiches

7 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared

8 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/doctors-scientific-organica-announces-voluntary-recall-limited-quantity-burn-boot-camp-afterburn

9 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kwik-trip-inc-recalls-specific-fruit-cups-and-trays-due-potential-salmonella-contamination

10 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/agriculture-department-warns-consumers-discard-hilltop-meadow-farm-brand-contaminated-60-day-aged

11 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral

12 https://www.fsis.usda.gov/recalls-alerts/pelleh-poultry-corp–recalls-ready-eat-beef-and-poultry-products-due-possible

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