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,…

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…

This is an update to an Early Alert. The affected products and recommendations for what to do with the devices below have not changed. 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…

This is an update to an Early Alert. The affected products and recommendations for what to do with the devices below have not changed. 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…

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 Argon…

Summary Company Announcement Date: July 24, 2026 FDA Publish Date: July 27, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain particulate matter Company Name: American Regent, Inc. Brand Name: Brand Name(s) American Regent, Inc. Product Description: Product Description Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Company Announcement…

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 ENROUTE NPS ENROUTE NPS Plus The FDA is aware that Boston Scientific has issued a letter to affected customers…

Summary Company Announcement Date: July 24, 2026 FDA Publish Date: July 24, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as steel Company Name: Sunny Pharmtech, Inc. Brand Name: Brand Name(s) Long Grove Pharmaceuticals Product Description: Product Description Cyclophosphamide for Injection Company Announcement July 24, 2026 – Taoyuan…

Summary Company Announcement Date: July 24, 2026 FDA Publish Date: July 24, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Particulate matter (cardboard) found in the solution. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Cefazolin in Dextrose Injection Company Announcement July 24, 2026 – DEERFIELD, Ill., Baxter…

Summary Company Announcement Date: July 18, 2026 FDA Publish Date: July 20, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential cross contamination with Ranitidine Company Name: Unique Pharmaceutical Laboratories Brand Name: Brand Name(s) Rising Pharma Holdings Inc. Product Description: Product Description Cetirizine Hydrochloride Tablets USP 5 mg Company Announcement FOR IMMEDIATE RELEASE…