Pharma & Drug Safety

Warning Letter to buydeltas.com for Unlawful Nicotine Pouch Sales

The FDA Center for Tobacco Products issued a warning letter to buydeltas.com on March 27, 2026, for selling unauthorized nicotine pouch products (ZYN Nicotine Pouches - Cucumber Lime Slim 6.5MG and Red Fruits Slim 9MG) without required premarket authorization. The products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the Federal Food, Drug, and Cosmetic Act. The company must immediately cease selling all unauthorized tobacco products.

Henan Lvyuan Pharmaceutical Co. Ltd. - CGMP Violations Warning Letter

The FDA Center for Veterinary Medicine issued Warning Letter 320-26-55 to Henan Lvyuan Pharmaceutical Co. Ltd., a Chinese manufacturer of active pharmaceutical ingredients (APIs) for veterinary and human drug compounding. The inspection from September 22-26, 2025 revealed significant CGMP violations including inadequate facility maintenance with extensive corrosion and water leaks that could contaminate APIs and compromise drug quality. The company must respond within 15 business days with corrective actions or face regulatory action including detention of products at U.S. borders.

Contract Testing Laboratory CGMP Violations - Microbiological Testing & Consulting LLC

FDA issued Warning Letter 320-26-53 to Microbiological Testing & Consulting, LLC (FEI 3003875820) on March 16, 2026, citing significant CGMP violations found during a September 8-16, 2025 inspection of their contract testing laboratory in Alsip, IL. The agency identified failures in laboratory controls, inadequate documentation practices, and lack of appropriate media qualification for microbiological testing of drug products under 21 CFR parts 210 and 211.

FDA Identifies Serious Liver Injury Cases and Deaths with Tavneos

FDA issued a Drug Safety Communication alerting healthcare professionals and patients about serious postmarketing cases of drug-induced liver injury (DILI), including fatal outcomes, associated with Tavneos (avacopan). FDA identified 76 cases of DILI with reasonable evidence of causal association, including 8 deaths and 54 hospitalizations; some cases involved vanishing bile duct syndrome (VBDS). Healthcare professionals are now advised to conduct enhanced liver monitoring (every 2 weeks for the first month, then monthly for 5 months) and to discontinue treatment if liver enzymes exceed specified thresholds.

Virtual Control Groups to Reduce Animal Testing in Medicines Development

EMA's CHMP has issued a draft qualification opinion for virtual control groups (VCG) to replace concurrent animal control groups in rat dose-range finding studies. The consultation runs from 31 March to 12 May 2026, inviting comments from the scientific community and stakeholders on this new approach methodology (NAM).

Monthly Drug and Medical Device Safety Roundup

MHRA published its monthly safety roundup for March 2026, consolidating alerts on medicines and medical devices. The roundup includes multiple drug and device batch recalls affecting various therapeutic areas. Healthcare providers and patients should review the specific alerts to identify affected products in their supply chain or treatment.

Clinical Investigations in Northern Ireland for Medical Devices

MHRA published guidance clarifying clinical investigation requirements for medical devices in Northern Ireland under the EU Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746. Manufacturers must notify MHRA when using non-UKCA or non-CE marked devices on human participants. The guidance establishes that a single EU MDR application covers sites in both Northern Ireland and Great Britain.

Clinical investigations for medical devices

MHRA published guidance explaining requirements for clinical investigations of medical devices in Great Britain under the UK MDR 2002. Manufacturers must notify MHRA of planned investigations involving non-UKCA or non-CE marked devices on human participants unless an exemption applies. The guidance clarifies different regulatory pathways for Great Britain versus Northern Ireland.

Biological Safety Assessments for Clinical Investigations of Medical Devices

MHRA published new guidance on biological safety assessments for clinical investigations of medical devices. The guidance specifies the information MHRA expects in clinical investigation submissions to verify compliance with relevant regulations. This applies to manufacturers and sponsors conducting clinical investigations of medical devices in the UK.

Clinical investigations for electrically powered devices

MHRA published guidance on clinical investigations for electrically powered medical devices. The guidance explains additional information requirements for notifying the agency of planned clinical investigations. Sponsors and clinical investigators of electrically powered medical devices should follow these requirements when submitting notifications.

Clinical Investigations: Investigators' Responsibilities for Medical Devices

MHRA published guidance clarifying clinical investigators' responsibilities when conducting medical device investigations in the UK. The guidance covers submission requirements, MHRA's approval process, device labeling standards, and documentation requirements. This is informational guidance without new legal obligations.

Schreiber Foods Recalls Honey Almond Cream Cheese Due to Undeclared Almonds

Schreiber Foods, Inc. is recalling 144 cases of Honey Almond Cream Cheese Spread due to undeclared almonds. The product was distributed to Einstein Bros. Bagel locations in Colorado, Utah, New Mexico, and Wyoming. Consumers with almond allergies are urged to return the product for a refund.

Public Safety and Health Preparations for 2026 FIFA World Cup in Massachusetts

The Massachusetts Healey-Driscoll Administration has detailed public safety and health preparations for the 2026 FIFA World Cup, involving over 70 agencies and securing nearly $76 million in federal funding. A new online hub, Mass.gov/WorldCup, has been launched to provide information and resources.

E. coli Outbreak: Consumers Advised to Dispose of Raw Farm Cheddar Cheese

The Massachusetts Department of Public Health is advising consumers to discard Raw Farm-brand raw cheddar cheese due to an ongoing E. coli outbreak investigation linked to the product. Federal and state officials have identified seven illnesses across three states, with two hospitalizations, primarily affecting young children.

Virginia TB Cases Decrease, Diabetes Link, Resistant TB Noted

The Virginia Department of Health reported a 14% decrease in TB cases in 2025 compared to 2024, with 194 cases. The report noted an increase in drug-resistant TB and highlighted diabetes as a common comorbidity, affecting 27% of TB patients in 2025. World TB Day serves as a reminder for TB prevention and elimination efforts.

RHHD Urges TB Screening and Preventative Care Amidst Virginia Case Increase

The Richmond and Henrico Health Districts (RHHD) are urging community members to seek tuberculosis (TB) screening and preventative care, noting a 9% increase in Virginia cases in 2024. The notice highlights local TB data, symptoms, and available testing and treatment services through RHHD.

EMA Recommends Imdylltra for Relapsed Small Cell Lung Cancer

The European Medicines Agency (EMA) has recommended marketing authorisation for Imdylltra (tarlatamab) for adults with relapsed extensive-stage small cell lung cancer. This recommendation is based on Phase 3 trial data showing improved overall survival and progression-free survival compared to standard of care.

EMA Recommends Restricting Tecovirimat SIGA for Mpox Treatment

The EMA's Committee for Human Medicines has recommended restricting the use of Tecovirimat SIGA for the treatment of mpox. Clinical trials showed the medicine was not effective in healing lesions faster than placebo in mpox patients with active lesions. This recommendation does not affect other authorised uses of Tecovirimat SIGA.

Blueroot Health Recalls Aller-C Supplements for Undeclared Allergens

Blueroot Health is voluntarily recalling two lots of Vital Nutrients Aller-C dietary supplements due to undeclared egg, hazelnut, and soy. The recall affects nationwide distribution, and consumers with allergies to these ingredients are advised to return the product. No illnesses have been reported to date.

MHRA Guidance on Clinical Trials Quality and Risk Proportionality

The MHRA has issued new draft guidance on applying quality by design, risk-based quality management, and proportionate oversight in UK clinical trials. This guidance accompanies amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004, which come into force on April 28, 2026. The agency is seeking feedback on the draft guidance.

Pharmacy Policy on Reporting Loss or Theft of Controlled Substances

The Massachusetts Board of Registration in Pharmacy has issued Policy 2026-01, updating procedures for pharmacies and wholesalers to report confirmed losses or thefts of controlled substances. The policy requires reporting within 7 calendar days of discovery for all losses related to theft, pilferage, or diversion, regardless of quantity or schedule, and significant losses of Schedule II-VI substances.

Pharmacy Reporting Policy for Controlled Substance Loss or Theft

The Massachusetts Board of Registration in Pharmacy has issued Policy 2026-01, updating procedures for licensed pharmacies and wholesalers to report confirmed losses or thefts of controlled substances. The policy requires reporting within 7 days of confirmed losses, including those from theft, pilferage, or diversion, regardless of quantity or schedule, and significant losses of Schedule VI substances.

Falcon Trading Company Recalls Organic Black Beans for Pesticide Residue

Falcon Trading Company, Inc. is recalling organic black beans and related products due to the presence of pesticide residue. The recall affects all lot numbers of specific items sold in bulk. Consumers are urged to return the products for a full refund.

Gear Isle Recalls Chocolate for Undeclared Sildenafil and Tadalafil

Gear Isle is voluntarily recalling its Gold Lion and ilum chocolate products nationwide due to undeclared sildenafil and tadalafil. These ingredients can interact with prescription medications and pose a serious health risk. Consumers are advised to stop using the product and return it for a refund.

MHRA and HSA Collaborate on Healthcare Regulatory Innovation

The MHRA and Singapore's HSA have refreshed a Memorandum of Understanding to collaborate on healthcare regulatory innovation, focusing on emerging technologies like AI and advanced therapies. This partnership aims to accelerate patient access to innovative treatments while maintaining safety and trust through initiatives like work-sharing and a new Regulatory Innovation Corridor pilot.

Apixaban Tablets Defect Notification - MHRA

The MHRA has issued a defect notification for Sandoz Limited's Apixaban 2.5mg and 5mg tablets. Certain batches have been distributed with Patient Information Leaflets that lack up-to-date information regarding paediatric indications and post-catheter removal guidance. Affected batches will continue to be distributed without repackaging.

Vesomni Tablets Defect Notification - Incorrect Barcode

The MHRA issued a Class 4 Medicines Defect Notification regarding Quadrant Pharmaceuticals Limited's Vesomni 6 mg/0.4 mg modified release tablets. The parallel imported packs have an incorrect barcode/GTIN on the carton, but the product quality is unaffected. No recall is issued, and patients do not need to take action.

Amneal Pharmaceuticals Recalls Magnesium Sulfate Due to Product Mix-Up

Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, due to a product mix-up where a pouch contained an IV bag of Tranexamic Acid. The recall is to the hospital level nationwide. The company has received no adverse event reports related to this recall.

Navajo Heating Pad Recalled for Overheating and Burn Risk

The FDA has identified a Class I recall for Navajo Manufacturing Company's Handy Solutions Neck & Shoulders Heating Pad (Model 25607) due to an overheating and burn risk. The company is removing the affected devices from the market, and consumers are advised to immediately discontinue use, cut the power cord, and dispose of the product.

FDA Warning Letter to Matesbrand.com for Nicotine Pouches

The FDA issued a warning letter to matesbrand.com for illegally marketing new tobacco products, specifically nicotine pouches, without required premarket authorization. The agency determined that the listed nicotine pouch products are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to 4U Health for Adulterated Biologics

The FDA issued a warning letter to 4U Health for distributing an unapproved HIV serological diagnostic dried blood spot self-collection kit. The kit is considered adulterated and misbranded because it lacks the required premarket approval or investigational device exemption.

FDA Warning Letter to ImmunityBio Inc. Regarding ANKTIVA®

The FDA issued a warning letter to ImmunityBio Inc. concerning promotional communications for its drug ANKTIVA®. The FDA determined that a direct-to-consumer broadcast advertisement and a podcast were false or misleading, misbranding the drug and violating the Federal Food, Drug, and Cosmetic Act. The agency expressed concern that these communications create a misleading impression that ANKTIVA can cure or prevent all cancer.

FDA Warning Letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd.

The FDA issued a warning letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd. following an inspection that revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations. The company failed to adequately test drug products for identity and strength before release and did not properly test incoming components.

FDA Warning Letter to Longhorn Vaccines and Diagnostics LLC

The FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC regarding violations of the Quality System Regulation for their PrimeStore® MTM device. The inspection revealed that the devices are adulterated due to inadequate complaint file maintenance and failure to establish proper complaint handling procedures, including evaluating complaints for medical device reporting.

Massachusetts Extends RSV Immunizations for Infants Through April 30, 2026

The Massachusetts Department of Public Health has extended its recommendation for RSV monoclonal antibody immunizations for eligible infants through April 30, 2026, due to ongoing elevated RSV activity. This advisory urges healthcare providers to continue administering these preventive measures to protect vulnerable infants from severe illness.

NY Essential Plan Coverage Preserved for 1.3M New Yorkers

The New York State Department of Health announced federal approval to transition the Essential Plan back to Basic Health Program authority, preserving coverage for 1.3 million New Yorkers. However, approximately 450,000 individuals will lose eligibility for the Essential Plan starting July 1, 2026, and will instead be directed to Qualified Health Plans.

MHRA Phases Out Animal Testing with Early Data Review

The MHRA is phasing out animal testing by offering early reviews of non-animal data for drug marketing applications. This initiative aims to boost developer confidence in New Approach Methodologies (NAMs) and support the government's strategy to reduce animal use in research, while maintaining rigorous safety and efficacy standards.

MHRA Field Safety Notices for Medical Devices (March 16-20, 2026)

The MHRA has published a list of seven Field Safety Notices (FSNs) related to medical devices issued between March 16 and March 20, 2026. These notices are published for informational purposes, and recipients are advised to act on any FSN received from a manufacturer.

Hibiwash Recalled Due to Microbial Contamination

The MHRA has issued a precautionary recall for three batches of Hibiwash, an antimicrobial wash, due to microbial contamination identified at the manufacturing facility. Mölnlycke Health Care is advising healthcare professionals and retailers to stop supplying the affected batches and patients to stop using them.

Virginia Measles Cases Prompt Vaccination Encouragement

The Virginia Department of Health has reported 14 measles cases as of March 19, 2026, a significant increase from the five cases reported in all of 2025. The Richmond and Henrico Health Districts are encouraging parents to schedule well-child visits for immunizations before summer.

Meningitis Patient Factsheet and Vaccination Advice

The MHRA has published a patient factsheet on meningitis, providing information on the condition, its causes, symptoms, and the role of vaccination. The guidance also advises on reporting vaccine side effects through the Yellow Card scheme.

CDPH Warns of Illness Linked to Raw Cheddar Cheese

The California Department of Public Health (CDPH) is warning consumers and businesses not to eat, serve, or sell raw cheddar cheese manufactured by RAW FARM, LLC due to an outbreak of Shiga toxin-producing E. coli (STEC) O157. Seven cases have been reported across multiple states, with two hospitalizations, including two children under five.

FDA Requires Warning on Carbidopa/Levodopa for Vitamin B6 Deficiency Seizures

The FDA is requiring drug manufacturers to add a warning to carbidopa/levodopa products regarding the risk of vitamin B6 deficiency and associated seizures. Healthcare professionals are directed to monitor vitamin B6 levels and supplement as needed.

Cardinal Health Recalls Webcol Alcohol Prep Pads Due to Microbial Contamination

Cardinal Health is voluntarily recalling select lots of Webcol™ Large Alcohol Prep Pads due to microbial contamination with Paenibacillus phoenicis. The recall is being conducted to the consumer level due to the risk of serious infections. The product was distributed nationwide and internationally.

Massachusetts Pharmacist Medication Administration Guidance Update

The Massachusetts Department of Public Health issued a circular letter updating guidance on pharmacist medication administration. This update authorizes pharmacists to administer testosterone for gender-affirming care, and medications for the prevention and treatment of HIV and sexually transmitted infections, in addition to existing authorizations for mental illness and substance use disorder treatments.

Massachusetts Pharmacist Administration of Medications Guidance

The Massachusetts Department of Public Health issued guidance allowing pharmacists and pharmacy interns to administer additional medications, including testosterone for gender-affirming care, and treatments for HIV and STIs. This guidance replaces a previous version and provides details on eligibility and administration requirements.

MA Governor Supports Lifting Sunday Hunting Ban and Expanding Access

Massachusetts Governor Maura Healey announced support for legislation to modernize hunting laws, including lifting the Sunday hunting ban and expanding crossbow use. Concurrently, the MA Department of Public Health will raise awareness about alpha-gal syndrome and make it a reportable condition.

FDA Warning Letter to Vedic Lifesciences for GLP Violations

The FDA issued a warning letter to Vedic Lifesciences Pvt. Ltd. for violations of Good Laboratory Practice (GLP) regulations during the inspection of nonclinical laboratory studies. The company failed to prepare accurate final reports for investigational drug studies, misrepresenting testing facility and personnel information.

EMA Enhances PRIME Scheme to Accelerate Medicine Development

The European Medicines Agency (EMA) has launched three new features for its PRIME scheme, designed to accelerate the development of medicines targeting unmet medical needs. These tools aim to streamline scientific dialogue and provide developers with faster answers and better preparation for marketing authorisation applications.

Mama Grande Tortilla Factory Recalls Gorditas for Undeclared Wheat and Soy

Mama Grande Tortilla Factory is recalling Gorditas de Azucar and Doraditas de Azucar due to undeclared wheat and soy. The recall impacts products distributed in Texas between February 2, 2026, and March 5, 2026. No illnesses have been reported.