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FDA Warning Letter to PharmaZee for False Claims

The FDA issued a warning letter to PharmaZee for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that PharmaZee misrepresented itself as the compounder and implied FDA approval for these unapproved drugs, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Good Girl LLC for False Claims

The FDA issued a warning letter to Good Girl LLC (dba GoodGirlRX) for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The company claimed the products were 'FDA-approved' and that GoodGirl RX was the compounder, which the FDA states is false and misbrands the drugs.

FDA Warning Letter to Peaks Curative for False Claims

The FDA issued a warning letter to Peaks Curative, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented its compounding practices and implied FDA approval for products that are not FDA-approved, leading to misbranding violations.

FDA Warning Letter to Refills Health for False Claims

The FDA issued a warning letter to Refills Health, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented itself as the compounder and made unsubstantiated claims such as 'clinically proven,' leading to the products being considered misbranded under the FDCA.

FDA Warning Letter to Ivim Services LLC for Misbranded Drugs

The FDA issued a warning letter to Ivim Services LLC for introducing misbranded compounded semaglutide and tirzepatide products into interstate commerce. The agency found that Ivim's website made false or misleading claims, suggesting Ivim was the compounder when it was not, violating the Federal Food, Drug, and Cosmetic Act.

Transport Canada Truck Recall - Electrical Issue

Transport Canada has issued a recall for certain Western Star and Freightliner trucks due to an improperly installed tarp system relay that poses a fire risk. Owners will be notified by mail to inspect and potentially reinstall the relay.

Ford SUV Recall - Fuel Injector Leak Risk

Transport Canada has issued recall 2024160 for certain 2022-2023 Ford Escape and Bronco Sport models due to a risk of fuel leaks from cracked fuel injectors, which could lead to engine compartment fires. Ford will notify owners to update software and install a drain tube, with an extended warranty for injector replacement.

Ford Escape, Bronco Sport Recall - Fuel Injector Crack

Transport Canada has issued a recall for certain 2020-2022 Ford Escape and Bronco Sport vehicles due to a potential fuel injector crack, which could lead to a fuel leak and fire risk. Ford will notify owners to update software and install a drain tube, with an extended warranty for injector replacement.

Integra LifeSciences Recalls MediHoney and CVS Wound Dressings

The FDA announced a recall initiated by Integra LifeSciences for certain MediHoney and CVS Wound Gel products due to packaging failures that could lead to infection or delayed care. The recall involves removing affected products from service and distribution. Integra LifeSciences has reported 11 serious injuries related to MediHoney and three related to CVS Wound Gel.

Ramipril Recall Due to Packaging Error

The MHRA has issued a precautionary recall for one batch of Ramipril 5 mg Capsules (Batch Number GR164099) due to a packaging error that may have resulted in Amlodipine 5 mg Tablets being included in the cartons. Pharmacy and healthcare professionals are advised to return remaining stock to suppliers.

UK Agencies Support In-Orbit Pharmaceutical Manufacturing

The UK Space Agency, MHRA, RIO, and CAA have issued a joint statement outlining their support for companies involved in in-orbit pharmaceutical manufacturing. This initiative aims to foster a supportive regulatory environment through guidance and collaborative studies, reinforcing the UK's commitment to space-enabled manufacturing.

MHRA Class 2 Recall: Crescent Pharma Ramipril 5mg Capsules

The MHRA has issued a Class 2 medicines recall for one batch of Crescent Pharma Limited's Ramipril 5mg Capsules due to a manufacturing error where incorrect blister strips were found in the packaging. Healthcare professionals are instructed to stop supplying the affected batch immediately and contact patients who received the product.

BMW Motorcycle Recall - Turn Signals May Not Work

Transport Canada has issued a recall for BMW motorcycles due to a potential defect in the left combination switch, which may prevent turn signals from functioning. The issue poses a safety risk, as non-functional turn signals could increase the risk of a crash. Affected motorcycles have not yet been delivered to customers.

Honda and Acura SUV Recall - Instrument Cluster Display Issue

Transport Canada has issued a recall for 2024 Honda Prologue and Acura ZDX SUVs due to a software issue that can cause the instrument cluster and infotainment display to go blank while driving. This poses a safety risk by preventing drivers from seeing critical information and the rearview camera.

International Motors School Bus Brake Lines Recalled

Transport Canada has issued a recall for International Motors school buses due to a potential issue with brake lines not being secured correctly. This could lead to brake fluid leaks and reduced braking capability, increasing the risk of a crash. Owners will be notified to have the brake lines inspected and replaced.

International Motors Bus Recall - Brake Line Issue

Transport Canada has issued a recall for certain 2025-2026 IC BUS CE COMMERCIAL BUS models manufactured by International Motors due to a potential brake line issue. The recall addresses the risk of reduced braking performance, increasing the risk of a crash.

Draft Guidance: Responding to FDA Form 483 Observations for Drug Manufacturers

The FDA has issued draft guidance for drug manufacturers on how to respond to observations noted on FDA Form 483 following CGMP inspections. This guidance is intended to assist domestic and foreign manufacturers in assessing conformity with CGMP requirements.

Lifeworks Technology Massage Guns Recalled as Unauthorised Device

Health Canada has recalled Lifeworks Technology Vibra-Heal and Restore Massage Guns because they were distributed without a valid medical device licence. Sales have ceased, and the company plans to apply for the necessary licence.

Olympus MAJ-1443 and MAJ-1444 Valves Recall

Health Canada has issued a Type II recall for Olympus MAJ-1443 and MAJ-1444 valves. These valves are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors and require reprocessing via updated instructions. Healthcare providers should contact the manufacturer for further information.

Health product recall: APO-BRIMONIDINE-TIMOP weight out of specification

Health Canada has issued a recall for APO-BRIMONIDINE-TIMOP due to a weight specification issue in lot VK2312. The recall is classified as Type II, indicating a low probability of adverse health consequences. Retailers are instructed to remove the affected product from shelves.

Shimadzu FDR Visionary Suite Health Product Recall

Health Canada has issued a Type II recall for Shimadzu Corporation's FDR Visionary Suite medical device due to a potential safety issue with the X-ray high voltage generator. The issue could lead to overheating and smoke. Healthcare providers are advised to contact the manufacturer for more information.

Medline Industries Recalls Catheters Due to Particulates and Infection Risk

The FDA has identified a Medline Industries catheter recall as the most serious type due to potential particulates causing infection or embolism. Affected product lots must be destroyed. This is an expansion of a previous recall.

FDA Warning Letter to Premium Health Management

The FDA issued a warning letter to Premium Health Management Inc. for misbranding compounded semaglutide and tirzepatide products. The company's website made false or misleading claims about the products, suggesting they were compounded by Premium Health when they were not, and implying FDA approval or evaluation.

EMA Draft Guidance on Clinical Trials During Public Health Emergencies

The European Medicines Agency (EMA) has published draft guidance for conducting clinical trials during public health emergencies. This guidance, open for consultation until April 30, 2026, aims to streamline the authorization of new trials and modifications to ongoing trials.

Frito-Lay Recalls Chips for Undeclared Milk Allergen

Frito-Lay is voluntarily recalling select 8 oz. bags of Miss Vickie's Spicy Dill Pickle Potato Chips due to undeclared milk allergen. The recall affects products distributed in Arkansas, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas. No allergic reactions have been reported to date.

FDA Safety Communication on Choking Rescue Protocols and Devices

The FDA is issuing a safety communication to encourage the public and healthcare providers to follow established choking rescue protocols before using anti-choking devices. The agency highlights that established protocols, such as back blows and abdominal thrusts, are the most effective method and that using devices first could delay life-saving actions.

FDA Warning Letter to Las Americas Supermercado#2 Inc.

The FDA issued a warning letter to Las Americas Supermercado#2 Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The inspection revealed the company failed to develop and maintain an FSVP for imported foods, a violation of the Federal Food, Drug, and Cosmetic Act.

MHRA Field Safety Notices - February 23-27, 2026

The MHRA has published a list of five Field Safety Notices (FSNs) issued between February 23-27, 2026, for medical devices. These notices are for informational purposes, and recipients are advised to contact the manufacturer with any questions.

FDA Guidance on Real-World Data for Medicine Safety Assessment

The FDA has issued final guidance on using real-world data for medicine safety assessments, replacing a previous draft and withdrawing an older guidance. This document provides principles for planning, designing, analyzing, and reporting non-interventional studies utilizing real-world data for drugs and biological products.

FDA Final Guidance on Post-Approval Safety Data Reporting

The FDA has issued final guidance on post-approval safety data reporting, updating standards for managing and reporting individual case safety reports. This guidance clarifies the use of new data sources and replaces previous versions from 2003 and a draft from March 2024.

FDA Draft Guidance on 3-Year Exclusivity for Drug Products

The FDA has issued draft guidance to assist applicants requesting 3-year exclusivity for drug products. The guidance, available for public comment, clarifies the statutory and regulatory criteria for eligibility and provides recommendations on request content and format. This aims to support the Drug Competition Action Plan.

FDA Warning Letter to Strut Health, LLC

The FDA issued a warning letter to Strut Health, LLC on February 20, 2026, for misbranding compounded semaglutide and tirzepatide products. The company's website allegedly made false or misleading claims about these drugs, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Beta Bionics, Inc.

The FDA issued a warning letter to Beta Bionics, Inc. regarding violations of the Quality System Regulation for their iLet Dosing Decision Software and iLet ACE Pump. The letter details failures in corrective and preventive action procedures, including inadequate analysis of complaints leading to serious adverse health outcomes.

FDA Warning Letter to Diasol, Inc. for Medical Device Violations

The FDA issued a warning letter to Diasol, Inc. for manufacturing unapproved and misbranded medical devices, specifically disinfectants for hemodialysis systems. The company also violated Quality System Regulation requirements. The FDA has requested corrective actions to ensure compliance.

FDA Warning Letter to Yuyao City Boss Vegetable Factory

The FDA issued a warning letter to Yuyao City Boss Vegetable Factory Co. Ltd. for serious violations of food safety regulations, including failure to maintain processing records and fabrication of data. The violations relate to acidified foods intended for export to the United States.

FDA Warning Letter to John Yoder Farm

The FDA issued a warning letter to John Yoder Farm for serious violations of the Shell Egg Regulation (21 CFR Part 118) and the FD&C Act. The farm failed to implement a written Salmonella Enteritidis Prevention Plan and had other insanitary conditions. The FDA is concerned about the compliance status and potential health risks.

FDA Warning Letter to The Father's Table, LLC

The FDA issued a warning letter to The Father's Table, LLC, for serious violations of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food regulations. The inspection found Listeria monocytogenes in the facility, rendering ready-to-eat food products adulterated.

FDA Warning Letter to Black Sheep Egg Company

The FDA issued a warning letter to Black Sheep Egg Company, LLC, following an inspection that detected Salmonella in environmental samples from their shell egg processing facility. The company is cited for insanitary conditions and violations of the Shell Egg regulation, rendering their products adulterated.

FDA Warning Letter to Supercan Bully Sticks LLC

The FDA issued a warning letter to Supercan Bully Sticks LLC on September 24, 2025, following inspections that revealed serious violations of the Foreign Supplier Verification Program (FSVP) and Current Good Manufacturing Practice regulations. These violations were identified after a voluntary recall of pet treats due to Salmonella contamination.

FDA Warning Letter to GenoGenix LLC

The FDA issued a warning letter to GenoGenix LLC for serious deficiencies in drug production practices, including failures to meet conditions for outsourcing facilities and insanitary conditions. The company has ceased production and initiated a voluntary recall of drug products.

FDA Warning Letter to Kare Solutions LLC dba Zappy

The FDA issued a warning letter to Kare Solutions LLC dba Zappy for misbranding compounded drug products, including semaglutide, tirzepatide, and liraglutide. The agency found that Zappy's website made false or misleading claims about these products, suggesting they were FDA-approved or compounded by Zappy when they were not.

FDA Import Alert: GLP-1 Receptor Agonist Bulk Drug Substances

The FDA has issued Import Alert #66-80, placing Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances on Detention Without Physical Examination. This action is due to concerns that these substances, used in compounding, may be adulterated and not meet current good manufacturing practice (CGMP) requirements.

FDA Import Alert 16-120: Detention of Non-Compliant Fish Products

The FDA has updated Import Alert 16-120, revising guidance for field personnel regarding the detention without physical examination (DWPE) of fish and fishery products from foreign processors not in compliance with the Seafood HACCP regulation. The update includes changes to the title, reason for alert, and guidance sections, incorporating foreign remote regulatory assessments as a compliance verification method.

FDA Import Alert 98-06: New Tobacco Products Detained Without Authorization

The FDA has updated Import Alert 98-06, which detains new tobacco products lacking required marketing authorization. This revision clarifies guidance and agency contacts, noting that ENDS products are now covered under a separate alert (98-07). Manufacturers and importers must ensure proper authorization to avoid detention.

Savannah Bee Company Recalls BBQ Sauce Due to Undeclared Allergens

Savannah Bee Company is recalling its Honey BBQ Sauce-Mustard due to undeclared wheat and soy allergens. The recall was initiated after a customer reported mislabeled products containing the 'Honey BBQ Sauce-Sweet' ingredients. Consumers are urged to dispose of the product and seek a refund.

MHRA Statement on Pathways Clinical Trial Safety

The MHRA has issued a statement regarding the Pathways clinical trial, emphasizing participant safety. As a precaution, Professor Jacob George has been recused from further involvement due to social media posts made prior to his appointment.

EMA Recommends Ojemda for Paediatric Low-Grade Glioma

The European Medicines Agency (EMA) has recommended a conditional marketing authorisation for Ojemda (tovorafenib) to treat paediatric low-grade glioma in patients aged 6 months and older with specific BRAF gene alterations. This recommendation addresses an unmet medical need for a targeted therapy in this patient population.

EMA CHMP Recommends 12 Medicines for Approval

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and six for extension of therapeutic indications. This includes novel treatments for influenza, COVID-19, paediatric brain tumours, Parkinson's disease, and several biosimilar medicines.

FDA Draft Guidance on Medical Gases Certification Process

The FDA has issued draft guidance for industry on the certification process for designated medical gases. This guidance explains the certification process and annual reporting requirements, aiming to reduce regulatory burden for the medical gas industry. Comments are due by April 13, 2026.

FDA Guidance: Plausible Mechanism Framework for Individualized Genetic Therapies

The FDA has issued draft guidance outlining a plausible mechanism framework for developing individualized genetic therapies. This framework provides recommendations for generating substantial evidence of effectiveness and safety for these novel treatments. The comment period for this draft guidance closes on April 27, 2026.