December 22, 2024 – December 28, 2024 – 3 Recalls (3 FDA, 0 USDA)

Industries/Products: Confections, Drugs

Current FDA & USDA Recall Trends

FDA

Recalls / Reason(s)

• 12/27/24 – Food & Beverage – Chocolate Candy Bars – Undeclared Tree Nuts (Cashews).
  • “The recall was initiated after it was discovered that the tree nut-containing product was distributed in packaging that did not reveal the presence of tree nuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.” 1
• 12/24/24 – Drugs – Tacrolimus and Tacrolimus Extended-Release capsules – Bottles may contain empty capsules.
  • “FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”) is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules.” 2
• 12/23/24 – Drugs – Lubricant Eye Drugs – Due to Fungal Contamination.
  • “FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.” 3

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gardners-candies-issues-allergy-alert-undeclared-tree-nuts-cappuccino-meltawayr-bars-and-gardners

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astellas-pharma-us-inc-issues-voluntary-nationwide-recall-one-lot-prografr-05mg-tacrolimus-and-one

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alcon-laboratories-issues-voluntary-nationwide-recall-one-1-lot-systane-lubricant-eye-drops-ultra-pf