Summary Company Announcement Date: August 27, 2026 FDA Publish Date: August 31, 2026 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP) Company Name: Ana Salazar Modela Tu Cuerpo Inc. Brand Name: Brand Name(s) Product Description: Product Description Lipofit Extreme 2.0 Fat Burner Dietary Supplement Company Announcement FOR IMMEDIATE…
Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
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. The FDA is aware that Medtronic and their subsidiary Given Imaging, Inc. have issued a letter to affected customers recommending…
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 27, 2026 FDA Publish Date: August 28, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as iron oxide Company Name: B. Braun Medical Inc. Brand Name: Brand Name(s) Product Description: Product Description 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL…
Early Alert: Angiographic 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 The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all Imager II…
Early Alert: IV Start Kit Issue from Avid Medical
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 Avid Medical has issued a letter to affected customers recommending certain convenience kits affected…
Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
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 AVID Medical…
Baxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection Due to Potential Presence of Particulate Matter
Summary Company Announcement Date: August 25, 2026 FDA Publish Date: August 26, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of particulate matter identified as fiberglass in the solution. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic…
Baxter Issues Voluntary Nationwide Recall for One Lot of 70% Dextrose Injection Due to Potential Presence of Particulate Matter
Summary Company Announcement Date: August 25, 2026 FDA Publish Date: August 25, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of particulate matter identified as stainless steel particles in the solution. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description 70% Dextrose Injection, USP in 2000 mL…
Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
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 NOxBOX has issued a letter to affected customers recommending certain nitric oxide delivery systems…
Optimal Balance 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 19, 2026 FDA Publish Date: August 20, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Elevated Endotoxin level Company Name: Optimal Balance Pharmacy Brand Name: Brand Name(s) Optimal Balance Pharmacy Product Description: Product Description Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial Company Announcement FOR IMMEDIATE RELEASE – August 19,…