October 2023 – 10/1 –10/7 – 7 Recalls (5 FDA, 2 USDA) 4 Food, 3 Drug

Current FDA & USDA Recall Trends

FDA

Recall / Contributing Factor(s)

• 10/6/23 – Food & Beverage – Pina Colada + Kratom Seltzer – Undeclared Tree Nut (Coconut) and Milk
  • “The recall was initiated after it was discovered that product containing (the allergen) was distributed in packaging that did not reveal the presence of tree nuts (coconut) and milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.” ¹
• 10/4/23 – Food & Beverage – Chocolate Flavored Protein Powder – Undeclared Sesame
  • “A co-manufacturer inadvertently used sesame in a limited production of Orgain’s Organic Protein + Superfoods, Creamy Chocolate Fudge flavor. The co-manufacturer informed Orgain that the product was distributed with an undeclared sesame allergen and Orgain initiated the recall.” ²
• 10/3/23 – Drugs – Betaxolol Tablets, USP – Potential Presence of Oxycodone HCl tablet
  • “The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time.” ³
• 10/2/23 – Drugs – 2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP – Potential Presence of Glass Particulates
  • The recall was initiated due to the potential for presence of glass particulate matter.⁴
• 10/2/23 – Drugs – Nasal Spray – Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp.
  • “FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp (these microorganisms are generally non-pathogenic).”⁵

USDA

• 10/6/23 – Food – RTE Ham – Possible Listeria Contamination
  • “The problem was discovered after the establishment’s laboratory testing indicated the product may be contaminated with Listeria monocytogenes. The establishment notified FSIS that some of the affected product was distributed into commerce.” ⁶
• 10/6/23 – Food – RTE Stuffed Pepper Soup with Meatballs – Misbranding and Undeclared Allergens
  • “The problem was discovered during a label review by the establishment.” ⁷

¹ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kula-brands-llc-issues-allergy-alert-undeclared-coconut-and-milk-kula-can-pina-colada-kratom-seltzer

² https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/orgain-issues-allergy-alert-undeclared-sesame-organic-plant-protein-superfoods-powder-creamy

³ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-one-lot-betaxolol-tablets-usp-10-mg-batch-number

⁵ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/biomic-sciences-issues-voluntary-nationwide-recall-ion-sinus-support-ion-sinus-and-restore-sinus

⁶ https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-kirkland-signature-ready-eat-ham-products-due

⁷ https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-a-ready-eat-stuffed-pepper-soup-meatballs-product

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