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…
Early Alert: Percutaneous Catheter Issue from Boston Scientific
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…
Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter
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…
BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION
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…
Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine
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…
Early Alert: Intravascular Administration Set 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 a letter to affected customers recommending certain Duo-Vent solution sets be…
Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
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 Abiomed has issued a letter to affected customers recommending all 14Fr Low Profile Introducer…
Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
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 Arrow International…
Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
This recall involves removing certain devices 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. Affected Product The FDA is aware that B. Braun Medical, Inc. has issued a letter to affected…
Early Alert: Ventilator Issue from Resmed
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 Figure 1. Astral 150. The FDA is aware that Resmed has issued a letter to affected customers recommending that…