April 21, 2024 – April 27, 2024 – 4 Recalls (4 FDA, 0 USDA)

Current FDA & USDA Recall Trends

FDA

Recall / Contributing Factor(s)

• 4/26/24 – Food & Beverage – Queso de Mano PAISA – Potential to be contaminated with Listeria monocytogenes.
  • “The recall was initiated after one laboratory analysis came out suspicious of that lot sample being contaminated. After a second analysis, this was confirmed. No illnesses have been reported to date in connection with this problem.” 1
• 4/23/24 – Drugs – Sapropterin Dihydrochloride Powder for Oral Solution 100 mg – Decreased Potency.
  • “FOR IMMEDIATE RELEASE Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.” 2
• 4/23/24 – Drugs – Herbal Dietary Supplement – Product is tainted with Nortadalafil.
  • “FOR IMMEDIATE RELEASE – 04/22/2024– Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nortadalafil in Schwinnng capsules makes it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall.” 3
• 4/22/24 – Food & Beverage – Avocado oil – Glass prone to breakage, causing product to spill.
  • “Primal Kitchen is announcing a voluntary recall of approximately 2,060 cases of three code dates of Primal Kitchen Avocado Oil (750mL) because the glass may be prone to breakage, causing the product to spill.” 4

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tama-corporation-recalls-product-because-possible-health-risk

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stop-clopez-corp-issues-voluntary-worldwide-recall-schwinnng-capsules-due-presence-undeclared

4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/primal-kitchen-issues-voluntary-recall-primal-kitchen-avocado-oil-750ml-glass-due-packaging-issue