FDA Recalls and Warnings: Epilepsy Drug Mix-Up, Subpotent Thyroid Medication, and More

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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions.  In this installment, we cover recalls involving amlodipine and olmesartan, Abirtega, Brush Buddies, Aru, and Evo toothpastes, Levoxyl, perampanel, and telmisartan and amlodipine, along with an FDA warning about the 10 Day Forecast male sexual enhancement supplement.<br><br>Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall. </p>
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<h2 class="wp-block-heading">How To Read This Report</h2>
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<h3 class="wp-block-accordion-heading has-icon has-icon-right"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Recalls (Enforcement Reports Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified."</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
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<li>Class I recalls are the most serious. In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death."</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.<br></p>
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<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Amlodipine and Olmesartan Medoxomil Tablets (generic for Azor)</h3>
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<p><strong>Drug Purpose</strong>: A combination medication used to treat high blood pressure. Contains calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (olmesartan medoxomil).<br><strong>Company</strong>: Ascend Laboratories, LLC<br><strong>Manufacturing Location</strong>: India (Alkem Laboratories Ltd.)<br><strong>Scope</strong>: 11,424 30-count bottles of 10 mg/40mg tablets<br><strong>Recall Reason</strong>: Failed dissolution specification; the tablets may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: October 6, 2026<br><strong>Recall Level:</strong> Class II<br><strong>Essential Extras</strong>: Ascend had previous recalls for Amlodipine and Olmesartan Medoxomil Tablets in <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98874">May 2026</a> and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99385">July 2026</a>.  <br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100053">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Abirtega (Abiraterone Acetate) Tablets</h3>
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<p><strong>Drug Purpose</strong>: Treats metastatic prostate cancer; to be used along with prednisone.<br><strong>Company</strong>: Hikma Pharmaceuticals USA Inc.<br><strong>Manufacturing Location</strong>: Sahab, Jordan, by Arab Pharmaceuticals Manufacturing PSC, for Hikma Pharmaceuticals USA Inc., Berkeley Heights, New Jersey<br><strong>Scope</strong>: 2,136 120-count bottles of 250 mg tablets<br><strong>Recall Reason</strong>: The tablets failed specifications for weight uniformity, which could affect consistent dosing. <br><strong>Recall Initiation Date</strong>: October 6, 2026<br><strong>Recall Level:</strong> Not yet classified<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100046">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Brush Buddies Anti-Cavity Fluoride Toothpaste: 13 products including Peppermint, Cookies and Cream, Chocolate, Vanilla, Crayola Silly Scents and more<br>evo Toothpaste: Advanced Whitening Anticavity Peppermint and Sensitive Anticavity Sweet Mint<br>Aru Toothpaste: Cavity Protection Cool Mint and Gum Health Soothing Mint </h3>
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<p><strong>Drug Purpose</strong>: Fluoride toothpaste for preventing cavities<br><strong>Company</strong>: PRITAM INTERNATIONAL PRIVATE LIMITED<br><strong>Manufacturing Location</strong>: Haridwar, India; distributed by Ashtel Studios Inc., Ontario, California<br><strong>Scope</strong>: More than 4 million tubes of toothpaste for 17 toothpaste products, including 13 Brush Buddies products, 2 Aru brand products and 2 evo brand products, distributed nationwide<br><strong>Recall Reason</strong>: CGMP (Current Good Manufacturing Practice) deviations; this could affect product quality.<br><strong>Recall Initiation Date</strong>: September 10, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99849">FDA Enforcement Report</a> </p>
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<h3 class="wp-block-heading">Levoxyl (Levothyroxine Sodium) tablets</h3>
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<p><strong>Drug Purpose</strong>: Prescription thyroid hormone replacement used to treat hypothyroidism<br><strong>Company</strong>: Pfizer<br><strong>Manufacturing Location</strong>: Austria; distributed by Pfizer Inc., New York, New York<br><strong>Recall Reason</strong>: Subpotent; the amount of active ingredient was less than the allowable range in stability testing<br><strong>Recall Initiation Date</strong>: September 29, 2026<br><strong>Recall Level:</strong> Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99963">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Perampanel Tablets (generic for Fycompa)</h3>
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<p><strong>Drug Purpose</strong>: Epilepsy treatment for people age 4 and older; classified as a <a href="https://medshadow.org/drug-classifications-schedule-ii-iii-iv-v/">Schedule III</a> controlled drug because of its potential risk for abuse or dependence.<br><strong>Company</strong>: Sun Pharmaceutical Industries, Inc.<br><strong>Manufacturing Location</strong>: Haifa Bay, Israel, by Taro Pharmaceutical Industries Ltd.<br><strong>Scope</strong>: 3,456 30-count bottles of 6 mg tablets<br><strong>Recall Reason</strong>: Labeling mix-up; a bottle labeled as containing perampanel 6 mg tablets contained a 10 mg perampanel tablet. Perampanel tablets come in six strengths, ranging from 2mg to 12 mg.<br><strong>Recall Initiation Date</strong>: June 17, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99256">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Telmisartan and Amlodipine Tablets</h3>
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<p><strong>Drug Purpose</strong>: Treats high blood pressure with a combination of an angiotensin II receptor blocker (telmisartan) and a calcium channel blocker (amlodipine)<br><strong>Company</strong>: Viatris, Inc.<br><strong>Manufacturing Location</strong>: India for Mylan Pharmaceuticals Inc., Morgantown, West Virginia<br><strong>Scope</strong>: 21,620 30-count bottles of 40 mg telmisartan/5 mg amlodipine tablets<br><strong>Recall Reason</strong>: Superpotent; The telmisartan concentration may exceed the established potency specifications.<br><strong>Recall Initiation Date</strong>: October 1, 2026<br><strong>Recall Level:</strong> Class III<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100048">FDA Enforcement Report</a></p>
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<h2 class="wp-block-heading">Medication Health Fraud Notifications</h2>
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<h3 class="wp-block-heading">10 Day Forecast Capsules/Pills, 3200 mg </h3>
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<p><strong>Product Purpose</strong>: Promoted and sold as a men’s herbal dietary supplement for sexual enhancement<br><strong>Scope</strong>: Sold on various websites, including eBay.com, and possibly in some retail stores. <strong>Warning</strong>: The FDA is advising consumers not to purchase or use 10 Day Forecast because the product contains sildenafil and acetaminophen not listed on the product label.</p>
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<p>Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. It may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. This is especially concerning for people with diabetes, high blood pressure, high cholesterol, or heart disease, who commonly take nitrate-containing medications. <br><strong>Warning Date:</strong> October 15, 2026<br><strong>Link</strong>: <a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/10-day-forecast-may-be-harmful-due-hidden-ingredients">10 Day Forecast Press Release</a> and <a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/sexual-enhancement-and-energy-product-notifications">Health Fraud Product Database for Sexual Enhancement and Energy Product Notifications<br></a>Check the Press Release for product photo and more information. </p>
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<h2 class="wp-block-heading">Additional Product Notifications </h2>
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<p>The Health Fraud Product Database contains additional public notifications about Sexual Enhancement and Energy Products, including recent warnings for these products:</p>
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<h4 class="wp-block-heading"><strong>Sold as men’s dietary supplements for sexual enhancement:</strong></h4>
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<p><a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/miracle-power-king-kong-honey-may-be-harmful-due-hidden-ingredient">Miracle Power of King Kong Honey</a>  (contains tadalafil, the active ingredient in Cialis)<br><a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/candy-power-man-may-be-harmful-due-hidden-ingredient">Candy Power For Man</a> (tadalafil)<br><a href="https://www.fda.gov/drugs/medication-health-fraud/public-notification-vital-honey-contains-hidden-drug-ingredient">Vital Honey</a> (tadalafil)<br><a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/deep-may-be-harmful-due-hidden-ingredient">DEEP</a> (tadalafil)</p>
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<h4 class="wp-block-heading"><strong>Sold as weight loss supplements:</strong></h4>
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<p><a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/beauty-911-may-be-harmful-due-hidden-ingredient">Beauty 911</a> (contains sibutramine). <a href="https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/questions-and-answers-about-fdas-initiative-against-contaminated-weight-loss-products">Sibutramine</a>, formerly sold under the brand name Meridia, was approved by the FDA in 1997 for the treatment of obesity and was subsequently withdrawn in December 2010 after clinical data indicated an increased risk of heart attack and stroke. Sibutramine is known to significantly raise blood pressure and/or heart rate in some people and may interact in life-threatening ways with other medications.<br><br><a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/luze-fit-intensity-may-be-harmful-due-hidden-ingredient">LUZE Fit Intensity</a> (contains sibutramine)</p>
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