Nationwide recall of Gas-X, Amlodipine, Epinephrine, Liraglutide; Safer Sunscreen Approved; How Dangerous Ingredients Get Into Food; New Warning for Migraine Meds; Choosing Hearing Aids and More
Popular Anti-Gas Drug Gas-X Potentially Contaminated with Coolant Recalled
Haleon, a consumer health brands company that makes over-the-counter medications for digestive health, has announced two recalls for Gas-x SoftGels (Simethicone).
The first recall involves 35,883 boxes (72-count and 120-count) of 125 mg Extra Strength Gas-x due to potential contamination with diluted propylene glycol-based coolant leaking into the product during the packaging process. Ingestion of the contaminated products may cause nausea, vomiting, abdominal pain and diarrhea. The FDA issued a FDA Press Release and an Enforcement Report. Check the press release for specific lot numbers. The product image in the press release indicates the medication was made in India.
The second, less serious recall involves 285,330 blister cards (120-count) of 125 mg strength Gas-X because the carton does not display all of the inactive ingredient information on its label. FDA Enforcement Report
Recall of Amlodipine and Olmesartan Medoxomil tablets by Ascend
Ascend Laboratories is recalling 15,696 bottles of the blood pressure drug amlodipine and olmesartan medoxomil (5 mg/40 mg) because the medication may not dissolve properly. In addition, the amount of active ingredient olmesartan medoxomil was found to be less than the required amount. This generic medication (Azor brand name) was made in India by Alkem Laboratories Ltd. Check this FDA Enforcement Report for expiration dates and lot numbers.
Recall of Duloxetine delayed-release capsules by Breckenridge
Breckenridge Pharmaceutical has a new recall for duloxetine delayed-release capsules (generic for the antidepressant Cymbalta), involving twice as many bottles as the recall announced last month. In the latest announcement, more than 359,000 bottles 60 mg strength tablets and 14,729 bottles of 30 mg strength tablets are being recalled due to nitrosamine impurities in the medication. The capsules were manufactured in Martorelles (Barcelona), Spain by Towa Pharmaceutical Europe S.L. This is Breckenridge’s fourteenth recall event for duloxetine due to nitrosamine impurities since 2024. Check this FDA Enforcement Report for expiration dates and lot numbers.
Recall of Epinephrine by Fresenius Kabi
Fresenius Kabi USA, LLC is recalling almost 900,000 single dose vials of the epinephrine injection due to quality failures for long-term stability testing. Epinephrine injections are used for emergency treatment of allergic reactions. Check the FDA Enforcement Report for expiration dates and lot numbers.
Recall of Liraglutide by Lupin
Lupin Pharmaceuticals is recalling 217,621 liraglutide pen injectors (6 mg/mL) in 2-Pen and 3-Pen packs because of the presence of white thread-like particulate matter in the cartridge. Liraglutide is a bioequivalent (generic) medication for GLP-1 diabetes treatment Victoza. This medication was made in Nagpur, India by Lupin. Check the Enforcement Report for lot numbers and expiration dates.
Moringa Capsules Dietary Supplement Recall
Total Nutrition Inc expanded its recall to 9 lots of its moringa dietary supplements TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules and Doctor’s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg. These products have been linked to more than 100 cases of salmonella nationwide. The supplements were sold on many online retailers and also on Total Nutrition’s website. The FDA and CDC have launched an investigation into the moringa-linked outbreak. Other brands have also been recalled. Check the FDA Press release for more information and product photos.
FDA Press Release (June 11) : Total Nutrition Inc. Expands Recall of TNVitamins and Doctor’s Pride Ultra Potent Complete Green Superfood Moringa Capsules Because of Possible Health Risk Following Further Supply Chain Review
From May 31 newsletter: Supplements-causing-nationwide-salmonella-outbreak-moringa-leaf-capsules-recalled
How Unsafe Ingredients Can Sneak Past FDA into our Food and Supplements
In June 2022, 393 people were sickened, and 133 were hospitalized, some with permanent organ damage, after eating a Daily Harvest brand lentil food product. Daily Harvest was using a food additive that was being marketed as a new superfood with a high protein ingredient called tara flour. The flour was never tested for safety. In this interview, Planet Money talks with a victim of the food poisoning (who had to have her gallbladder removed) and a lawyer at the Environmental Working Group who explains how companies can “sneak new chemicals past the FDA and into our food and supplements.” This radio interview is 3 minutes long; transcript is available:
How Companies Can Sneak New Chemicals Past the FDA and Into Our Food and Supplements
In April 2026, New York legislature passed a law that will require the food industry to disclose details about their use of “Generally Recognized as Safe” (GRAS) ingredients. It is awaiting the governor’s signature.
Food Safety Magazine: New-york-poised-to-ban-certain-food-additives-require-gras-ingredient-transparency
FDA Approves First New Sunscreen Ingredient in 20 Years
In December 2025, we reported that FDA was reviewing a new sunscreen ingredient called bemotrizinol. Last week, bemotrizinol was approved, with the FDA finding that it provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation. The ingredient has been used in sunscreen products in other countries for decades. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older. Until this approval, only Zinc and titanium dioxide had GRASE designation for use in sunscreens. (Check our previous article that explains why Avobenzone, Oxybenzone, and Octocrylene are still in sunscreens but are not considered GRASE.)
DSM Nutritional Products was granted exclusive rights for use of the ingredient for 18 months. Bemotrizinol is the first new active ingredient added as an authorized the over-the-counter (OTC) ingredient since the late 1990s. It will sell bemotrizinol to sunscreen makers under the brand name Parasol Shield and be available at concentrations up to 6% in over-the-counter sunscreen products. According to the People’s Pharmacy, the new products most likely won’t be available for sale in stores until Fall 2026 or even Spring 2027.
FDA Press Release: FDA-expands-sunscreen-options-first-time-in-20-years
The People’s Pharmacy: Safe Sunscreen at Last? FDA Approves First New UV Filter in 25 Years! Discover what it means for choosing a safe sunscreen. When can you buy it? (This article also reviews the safest sunscreen products to consider until the new product becomes available.)
New Warning for Migraine Treatments
A category of migraine headache medications carry a new warning about the risk of serious constipation that can result in hospitalization or surgery. The new warning applies to CGRP (calcitonin gene-related peptide) inhibitors and so far includes Ajovy, and Emgality, which are monoclonal antibody (“large molecule”) types.
The side effect was flagged for further FDA review in 2025 and the warning was added this month. If you are taking one of the CGRP drugs and experience severe constipation or symptoms such as severe or constant belly pain, vomiting, swelling of belly, or bloating, contact your doctor. Other migraine drugs flagged in 2025 but so far not receiving the new warning include Aimovig (also a monoclonal antibody), Nurtec ODT, Ubrelvy, and Zavspret.
Ask a Patient: “New Warnings for CGRP Migraine Headache Drugs: High Blood Pressure, Raynaud’s, Constipation”
Illegal Prescriptions Abound for Unapproved GLP-1 Retatrutide
More than 120 web sites and over 50 in-person clinics are marketing Retatrutide, an Eli Lilly GLP-1 experimental medication which has not yet been submitted for approval consideration by the FDA. The clinics are staffed by licensed physicians and nurse practitioners who claim that the clinical evidence is strong enough to bypass the standard regulatory timeline. In trials, retatrutide shows larger weight loss results than other GLP-1 drugs on the market. An FDA database check reveals that at least 16 warning letters have been sent to telehealth, online pharmacies, and compounding pharmacies for selling or promoting illegal retatrutide.
CBS News Investigation: Experimental Weight Loss Drug Doctors are Prescribing
Over-the-Counter Continuous Glucose Monitor (CGM) Approved for Kids Age 2 and Up
The FDA expanded approval of Dexcom Inc.’s Stelo Glucose Biosensor System, an over-the-counter (OTC) continuous glucose monitor (CGM), for use by children age 2 and up who do not use insulin. This would exclude Type 1 diabetes patients and Type 2 diabetes patients using insulin.
Stelo was approved for over-the-counter use by adults in 2024. A sensor worn on the skin pairs with an application on a compatible smartphone or other smart device, including a parent’s or caregiver’s phone, to continuously measure, record, and display glucose values every 15 minutes. There was no trial specific to children’s use of the device. Instead, “FDA drew on prior clinical study data from pediatric and adult populations, combined with real-world data on current iCGM use, to model expected device performance in children across the full 15-day wear period.”
Stelo is not intended for people with problematic low blood sugar (hypoglycemia), because the system is not designed to provide low blood sugar alerts. The device costs about $100 a month, and is not typically covered by insurance.
FDA Press Release: FDA-Clears-First-Over-Counter-Continuous-Glucose-Monitor-Children
Increasingly, adults are using CGMs for general wellness reasons, not because they are pre-diabetic or have diabetes. It is unclear why parents would monitor young children with this device, since children with Type-1 diabetes would be using insulin and ineligible and are unlikely to have Type-2. Adolescents using Wegovy or liraglutide for type 2 or obesity might be candidates, but they likely would use a CGM covered by insurance. Some teens however, might use it to monitor for prediabetes.
Here are three perspectives and testimonials about continuous glucose monitoring for wellness reasons:
Dr. Luis Gonzalez: Glucose Spikes or Business Spikes?
How Carb Phobia Fuels a Multi-Billion-Dollar Market
“What began as a legitimate warning about the risks of glucose spikes in metabolically vulnerable populations has, in the hands of certain influencers and companies, become an alarmist message directed at the general healthy population.” Dr. Gonzalez outlines documented risks, including the potential for constant monitoring that can “create added stress and fixation on normal blood glucose fluctuations.”
Jeff Krasno: Is This Right For Me? Continuous Glucose Monitors (CGM)
What Your Blood Sugar Is Actually Telling You
Krasno, owner of a masterclass platform for well-being, says that his experience using a CGM led him to understand that “your CGM is actually a stress monitor. Not by design. By accident. But it may be the most honest stress monitor you’ve ever worn.” He cautions that it is easy to become obsessed with checking your numbers. If you have a history of disordered eating or significant health anxiety, he recommends talking to a provider first. Also, he notes a study that showed that people respond dramatically differently to the same foods. One person’s healthy lunch is another person’s glucose spike.
Victoria Lee: “I Wore a Glucose Sensor 24/7 for 28 Days: A Physician’s 4-Week CGM Experiment”
Victoria Lee, a physician and wellness leader “on a mission to bridge ancient wisdom and modern science” and writer of Seoul to Soul used Abbot’s FreeStyle Libre 2 for four weeks and shares her experience. She also provides a table comparing key details about five CGM products (including the Dexcom’s Stelo).
Earlier this year: In February there was a recall of 3 million Abbot continuous glucose monitor sensors after malfunctions led to 860 injuries and 7 deaths because of falsely low glucose readings.
Ask a Patient Health News: Abbott-recalls-continuous-glucose-monitor-sensors-for-freestyle-libre-3-and-libre-3-plus-system
Medical Device Tips: Over-the-Counter Hearing Aids Recommendations
New York Times’ Wirecutter’s Over the Counter Hearing Aids and Other Hearing Solutions provides detailed reviews of its top three picks for over-the-counter hearing aids.
Wirecutter’s spreadsheet provides information for 22 of its previously-tested hearing aids and PSAPs (personal sound amplification products) that are still available, including Apple’s ear buds that function as hearing aids.
Wirecutter Competition Notes: Over the Counter Hearing Aids
Medication Tips: The Type of Water (or Beverage) You Drink Matters When Swallowing Your Pills
Researchers at Semmelweis University (Budapest, Hungary) studied how different liquids could affect enteric-coated medications. Tablets that are enteric-coated are designed so that the active ingredient is not released in the stomach (which is acidic) but later in the intestines (which is alkaline). Enteric coatings are commonly used on certain reflux medications, anti-inflammatory pain relievers, and digestive enzyme products.
The study analyzed 22 commonly consumed beverages, including detailed lab analysis of mineral and medicinal waters, tap water, filtered water, and apple juice. Alkaline bottled waters with high mineral content triggered premature drug release. By contrast, more acidic liquids, like apple juice, caused less damage to the enteric coating of the medications.
“Healthcare professionals generally assume that medications are swallowed with plain tap water, but that is not always obvious to patients today, given the wide variety of mineral and medicinal waters available on the market.” The study was published in Pharmaceutics. 2026;18(4).
Semmelweis University Press Release: “It Matters What Liquid You Take Your Medications With”
Did you miss the last edition? Read it here:
Really appreciated this timely piece as medication recalls are an important reminder that drug safety extends beyond prescribing to manufacturing and quality control. Transparent communication about recalls helps protect patients and reinforces the importance of pharmacovigilance throughout the supply chain. At the same time, I think it’s important for us to emphasize that recalls should prompt patients to verify whether their specific lot or product is affected rather than stopping medications abruptly, particularly for essential therapies such as antihypertensives. Decisions about discontinuation or replacement are best made in consultation with a pharmacist or physician. Really valuable update. This highlights how maintaining trust in healthcare depends not only on developing effective treatments, but also on ensuring their safety and quality every step of the way. Thanks for sharing this important information!
This is rich with essential warnings and lessons. It's especially disturbing how many medications have recalled due to accidents, errors and incompetence.