This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. The affected products and recommendations for what to do…
Early Alert: Positive Pressure Breathing Device Issue from Baxter
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Baxter has issued an Urgent Medical Device Correction notice to affected customers recommending all…
NARA ORGANICS RECALLS ALL LOTS OF NARA INFANT FORMULA BECAUSE OF POSSIBLE HEALTH RISK
Summary Company Announcement Date: June 13, 2026 FDA Publish Date: June 13, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential risk of Clostridium botulinum contamination. Company Name: Nara Organics Brand Name: Brand Name(s) Nara Organics Product Description: Product Description Whole Milk Powdered Infant Formula Company Announcement Nara Organics of New…
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product The FDA is aware that Medline…
Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination
Summary Company Announcement Date: June 11, 2026 FDA Publish Date: June 12, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Above acceptable microbiological limits for yeast and may contain Aspergillus spp. Company Name: Beekeeper’s Naturals Brand Name: Brand Name(s) Beekeeper’s Naturals Product Description: Product Description Saline Nasal Spray Company Announcement FOR IMMEDIATE RELEASE…
Azuma Foods International, Inc. Issues Allergy Alert on Undeclared Fish in Tako Wasabi
Summary Company Announcement Date: June 11, 2026 FDA Publish Date: June 12, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared fish. Company Name: Azuma Foods International, Inc. U.S.A Brand Name: Brand Name(s) Azuma Foods Product Description: Product Description Seasoned Octopus with Wasabi Company Announcement Azuma Foods International…
Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product The FDA is aware that Abiomed has…
Total Nutrition Inc. Expands Recall of TNVitamins and Doctor’s Pride Ultra Potent Complete Green Superfood Moringa Capsules Because of Possible Health Risk Following Further Supply Chain Review
Summary Company Announcement Date: June 11, 2026 FDA Publish Date: June 11, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Salmonella Contamination Company Name: Total Nutrition Inc. Brand Name: Brand Name(s) TNVitamins and Doctor’s Pride Product Description: Product Description TNVitamins Ultra Potent Complete Green Superfood Capsules and Doctor’s…
FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
AUDIENCE: Consumer, Patient, Health Care Provider, Pharmacy, Gastroenterology, Nephrology, Endocrinology ISSUE: The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to…
Clover Hill Dairy Recalls Soft Ricotta/Requeson Cheese Due to Possible Health Risk
Summary Company Announcement Date: June 09, 2026 FDA Publish Date: June 09, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes. Company Name: Clover Hill Dairy, LLC. Brand Name: Brand Name(s) Clover Hill Dairy Product Description: Product Description Soft Ricotta/Requeson Cheese Company Announcement…