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 Becton Dickinson (BD) has issued a letter to affected customers recommending certain Intraosseous Vascular…
Lexunder Inc Recalls Food to Live Brand Green Powder Products Because of Possible Health Risk
Summary Company Announcement Date: August 07, 2026 FDA Publish Date: August 07, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Salmonella Contamination Company Name: Lexunder Inc. dba Food To Live Brand Name: Brand Name(s) Food To Live Product Description: Product Description Green Powder Products Company Announcement Lexunder Inc.,…
Medline Industries, LP Issues Nationwide Recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
Summary Company Announcement Date: August 05, 2026 FDA Publish Date: August 06, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage Company Name: Medline Industries, LP Brand Name: Brand…
Victory Medical Center Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels
Summary Company Announcement Date: August 05, 2026 FDA Publish Date: August 05, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated Endotoxin level Company Name: Victory Medical Center Pharmacy Brand Name: Brand Name(s) Product Description: Product Description Compounded Glutathione 200 mg/mL Multi-Dose Vials Company Announcement FOR IMMEDIATE RELEASE – August 5, 2026 –…
Sun Noodle Issues Voluntary Recall of Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base Due to Undeclared Fish Allergen
Summary Company Announcement Date: August 05, 2026 FDA Publish Date: August 06, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Contain undeclared Fish Company Name: Sun Noodle of Honolulu Brand Name: Brand Name(s) Sun Noodle Product Description: Product Description Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup…
Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up
Summary Company Announcement Date: August 04, 2026 FDA Publish Date: August 05, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to a label mix-up Company Name: Fresenius Kabi Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL Company Announcement FOR IMMEDIATE RELEASE –…
Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package – 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate Matter
Summary Company Announcement Date: July 31, 2026 FDA Publish Date: August 04, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass Company Name: Liebel-Flarsheim Company, LLC Brand Name: Brand Name(s) Product Description: Product Description OPTIRAY Imaging Bulk Package (IBP) 350,…
Blank Slate Creamery Issues Allergy Alert on Undeclared Egg in Vegan Non-Dairy Frozen Dessert Coconut Fudge Sandwiches
Summary Company Announcement Date: August 04, 2026 FDA Publish Date: August 04, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared egg allergen Company Name: Blank Slate Creamery Brand Name: Brand Name(s) Blank Slate Creamery Product Description: Product Description Vegan Non-Dairy Frozen Dessert Coconut Fudge Sandwiches Company Announcement Blank Slate…
American Regent, Inc. Animal Health Issues Nationwide Recall of Two Lots of Adequan® Canine and Two Lots of Adequan® I.M. Due to Visible Glass Fiber Material in the Product
Summary Company Announcement Date: July 31, 2026 FDA Publish Date: August 03, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Visible glass fiber material in the product Company Name: American Regent, Inc. Animal Health Brand Name: Brand Name(s) American Regent, Inc. Animal Health Product Description: Product Description Adequan Canine Injection and Adequan i.m…
Boticelli Foods Recalls Bettergoods Pistachio Nut Butter Because of Possible Health Risk
Summary Company Announcement Date: August 03, 2026 FDA Publish Date: August 03, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Salmonella Contamination Company Name: Boticelli Foods Brand Name: Brand Name(s) Bettergoods Product Description: Product Description Pistachio Nut Butter Company Announcement Boticelli Foods of Melville NY, is recalling 1…