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Insulet Recalls Omnipod 5 Pods Due to Manufacturing Issue

Insulet Corporation is initiating a voluntary medical device correction for specific lots of Omnipod 5 Pods due to a manufacturing issue that may cause insulin leaks. The FDA has been notified of this action, which impacts approximately 1.5% of global production. Customers can check lot numbers online and request replacement pods.

FDA Warning Letter to thesnuslife.com for Nicotine Pouches

The FDA issued a warning letter to thesnuslife.com for selling nicotine pouch products to individuals under 21, deeming them misbranded. The company is required to take prompt action to address violations and ensure compliance with the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Rio Verde Food Service Inc.

The FDA issued a warning letter to Rio Verde Food Service Inc. on February 27, 2026, citing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation following an inspection in July 2025. The company's HACCP plan for Live Oysters was found to be inadequate in controlling critical limits for temperature during receiving and storage, and its corrective action plans were insufficient.

Primal Herbs Recalls Volume Due to Undeclared Sildenafil

Primal Supplements Group LLC is voluntarily recalling all orders of Primal Herbs Volume due to the undeclared presence of sildenafil, an active ingredient in Viagra. The FDA confirmed the undeclared ingredient, which poses a risk of dangerous blood pressure drops when interacting with nitrates.

FDA Identifies Infusion Pump Software Correction as Most Serious Recall

The FDA has identified a software correction for the Fresenius Kabi Ivenix Large Volume Pump as its most serious type of recall, indicating a potential risk of serious injury or death. Affected healthcare providers are urged to update the pump software to version 5.10.2 as soon as possible and implement temporary risk mitigation measures.

Medline Industries Recalls Electrophysiology and Ultrasound Catheters

Medline Industries is expanding a recall of reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. The FDA has classified this as the most serious type of recall, as the devices could cause serious injury or death. Affected customers are instructed to return or destroy the product.

Modern Warrior Recalls Dietary Supplement Due to Undeclared Ingredients

Modern Warrior is voluntarily recalling its 'Modern Warrior Ready' dietary supplement due to the presence of undeclared tianeptine, 1,4-DMAA, and aniracetam. The FDA is highlighting the serious health risks associated with these ingredients, including potential life-threatening cardiovascular events and suicidal ideation.

Navafresh Recalls Rheumacare Capsules Due to Elevated Lead Levels

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Rheumacare Capsules due to elevated lead levels found by the FDA. The recall impacts consumers nationwide and is being conducted with the FDA's knowledge.

FDA Recall of Silintan Capsules for Undeclared Meloxicam

Anthony Trinh, 123Herbals LLC is voluntarily recalling all lots of Silintan capsules due to the presence of undeclared meloxicam, an approved NSAID. The FDA analysis found the product to be an unapproved new drug, posing risks of serious health events.

Gold Star Distribution Recalls FDA Products Due to Contamination

Gold Star Distribution, Inc. is recalling all FDA-regulated products held at its facility due to rodent, avian, and insect contamination and insanitary conditions. The FDA determined the facility operated under insanitary conditions, posing a significant risk of product contamination and potential illness from microorganisms like Salmonella.