Summary Company Announcement Date: June 06, 2025 FDA Publish Date: June 06, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Church & Dwight Co., Inc. Brand Name: Brand Name(s) Zicam® and Orajel™ Product Description: Product Description Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs Company Announcement Church…
Infusion Pump Recall: False Alarm Issue with Infusion Pump from Smiths Medical
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 Smiths…
Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula
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 Product Names: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Unique Device…
Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination
Summary Company Announcement Date: June 02, 2025 FDA Publish Date: June 04, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Amneal Pharmaceutical LLC Brand Name: Brand Name(s) Product Description: Product Description Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg Company Announcement Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets,…
Cetirizine or Levocetirizine: Drug Safety Communication – FDA Warns About Risk of Severe Itching After Discontinuation of Long-Term Use of Allergy Medicines
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology ISSUE: The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been reported in patients who…
Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication
Date Issued: April 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. These tests may overestimate blood lead levels and…
Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen
This recall involves updating the Instructions for using these 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 following the updated instructions. Affected Product …
UMARY- USA.COM Issues Voluntary Nationwide Recall of UNAVY ÁCIDO HIALURÓNICO Caplets and UMOVY ÁCIDO HIALURÓNICO Caplets Due to the Presence of Undeclared Drug Ingredients Dexamethasone, Diclofenac and Omeprazole
Summary Company Announcement Date: May 21, 2025 FDA Publish Date: May 22, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description The product contains undeclared Dexamethasone, Diclofenac and Omeprazole Company Name: UMARY USA Brand Name: Brand Name(s) UNAVY & UMOVY Product Description: Product Description Unavy Acidio Hialuronico (30 caplets/850 mg) and Umovy Acidio Hialuronico…
FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Sacred Tattoo Ink Products Contaminated with Microorganisms
[Posted 05/07/2025] Audience Consumers who are considering a new tattoo Tattoo artists Retailers of tattoo inks Product FDA laboratory analysis has found that the following tattoo inks are contaminated with pathogenic microorganisms: Sacred Tattoo Ink, Raven Black; CI# 77266; Lot#: RB0624; Best Before: June 28 2027 Sacred Tattoo Ink, Sunny Daze; CI# 21095; Lot#: SD1124;…
FDA 101: Product Recalls
Image What Is a Recall? A recall is an action taken by a company to correct or remove from the market an FDA regulated product that violates U.S. laws and regulations. Recalls may be initiated voluntarily by a company, or at the request of the FDA. Recalls are important because they protect the public from…