AUDIENCE: Patient, Health Care Professional, Pharmacy, Pediatrics ISSUE: The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients younger than 6 years taking these…
Early Alert: Blood Pump Controller Issue from Abiomed
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk 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…
Early Alert: Infusion Pump Software Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product Spectrum V6 infusion pump startup screen Spectrum V8 infusion pump…
Mellace Family Brands California, Inc. Issues An Allergy Alert On Undeclared Milk Allergen In Wegmans Semi-Sweet Chocolate Nonpareils
Summary Company Announcement Date: June 25, 2025 FDA Publish Date: June 30, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk allergen Company Name: Mellace Family Brands California, Inc. Brand Name: Brand Name(s) Product Description: Product Description Semi-sweet Chocolate Company Announcement Mellace Family Brands California, Inc. of Warren, OH…
Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR
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 Name: AutoPulse NXT Platform Model: Model 200 Catalog Number: 8700-001070-1 Software Version:…
mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
AUDIENCE: Pediatrics, Pharmacy, Family Practice, Internal Medicine, Cardiology ISSUE: FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. Specifically,…
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Penicillin G Potassium Injection Vial Company Name: Sandoz Inc. Brand Name: Brand Name(s) Product Description: Product Description Cefazolin for Injection, USP, 1 gm vial Company Announcement Sandoz, Inc. (“Sandoz”) is…
Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
Summary Company Announcement Date: June 26, 2025 FDA Publish Date: June 27, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Sesame Company Name: SHANG HAO JIA, INC Brand Name: Brand Name(s) Product Description: Product Description Spicy Shredded Tofu Company Announcement Shang Hao Jia, Inc. of South El Monte, CA is…
Kilwins Quality Confections, LLC. Issues Allergy Alert on Undeclared Pecans in Mocha Truffles
Summary Company Announcement Date: June 25, 2025 FDA Publish Date: June 25, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared pecans Company Name: Kilwins Quality Confections, LLC Brand Name: Brand Name(s) Product Description: Product Description Mocha Truffles Company Announcement Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling…
Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers
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 Product Names: Medline Kits Containing Medtronic…