FDA Drug Recalls and Warnings: Common Blood Pressure Drug May Not Dissolve Properly, Novo Nordisk Warned

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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’re highlighting recalls for Amantadine, Diclofenac Topical Gel, iKids-Growth Capsules, Isotretinoin, Metoprolol, Midodrine, Nilotinib, Temozolomide, Wizcure’s Vista Tear eye drops and gels, and Wizcure’s BioGlow ophthalmic strips. Also, Novo Nordisk, the maker of Ozempic and Wegovy, received a warning letter for failing to report serious adverse events to the FDA.</p>
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<p>Unless otherwise specified, all of the recalls in this installment have been assigned a “Class II” level by the FDA (see below for recall types). These are supplier-level recalls and not directed at consumers. However, consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates.</p>
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<h3 class="wp-block-heading">Recalls (Enforcement Reports Database)  </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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<ul class="wp-block-list"><!-- wp:list-item -->
<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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<h3 class="wp-block-heading">Warning Letters (Warning Letters Database)</h3>
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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.</p>
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<h3 class="wp-block-heading">Drug Imports Alerts Database</h3>
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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">Amantadine Hydrochloride Capsules</h3>
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<p><strong>Company</strong>: AvKare, LLC<br><strong>Manufacturing Location</strong>: Not specified; AvKare is in Pulaski, Tennessee<br><strong>Scope</strong>: Unspecified quantity of 100 mg strength 50-capsule unit dose packs (5 x 10)<br><strong>Drug Purpose</strong>: Prevents and treats influenza A infections, manages symptoms of Parkinson’s disease, and drug-induced extrapyramidal (movement) reactions.<br><strong>Recall Reason</strong>: Failed dissolution specifications: the capsules may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: February 13, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98449">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Diclofenac Sodium Topical Gel</h3>
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<p><strong>Company</strong>: Sun Pharmaceutical Industries Inc.<br><strong>Manufacturing Location</strong>: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada<br><strong>Scope</strong>: Unspecified quantity of 3% strength, 100-gram tubes<br><strong>Drug Purpose</strong>: Prescription nonsteroidal anti-inflammatory drug (NSAID) used for the topical treatment of actinic keratoses (precancerous skin lesions caused by sun exposure)<br><strong>Recall Reason</strong>: Viscosity slightly below the acceptable limit: product might be too thick for ease of application.<br><strong>Recall Initiation Date</strong>: January 27, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98351">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">iKids-Growth (Day Formula and Night Formula) Capsules</h3>
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<p><strong>Company</strong>: Agebox<br><strong>Manufacturing Location</strong>: Not specified; Agebox Inc. is in Wilmington, Delaware<br><strong>Scope</strong>: 665 bottles of iKids-Growth Day Formula (60-count) and an unspecified number of iKids-Growth Night Formula (60-count) bottles<br><strong>Drug Purpose</strong>: Marketed as a children’s height and growth dietary supplement (“IGF‑1 sensitizer”).<br><strong>Recall Reason</strong>: Presence of undeclared ibutamoren (MK‑677), an unapproved growth hormone stimulator associated with serious side effects, including increased appetite, fluid retention, fatigue, muscle aches, blood sugar and insulin changes, and a potential increased risk of congestive heart failure.<br><strong>Recall Initiation Date</strong>: March 3, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98011">FDA Enforcement Report</a></p>
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<p><strong>Essential Extras</strong>: The FDA issued a <a href="https://www.fda.gov/drugs/medication-health-fraud-notifications/agebox-ikids-growth-day-formula-may-be-harmful-due-hidden-ingredient">Consumer alert</a> about this product in September 2025 and a<a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agebox-inc-718252-12192025"> Warning letter</a> to Agebox for marketing an unapproved drug that claims to make children grow taller. Ibutamoren (MK-677) has gained attention as a peptide <a href="https://www.getsmartaboutdrugs.gov/news-statistics/2025/07/08/beyond-hype-potential-health-risks-mk-677">body-building supplement</a> for adults, but it is a banned substance for athletes and is not FDA-approved.</p>
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<h3 class="wp-block-heading">Isotretinoin Capsules</h3>
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<p><strong>Company</strong>: Mylan Pharmaceuticals Inc.<br><strong>Manufacturing Location</strong>: Made in France for Mylan Pharmaceuticals, Morgantown, West Virginia<br><strong>Scope</strong>: 34,850 blister packs of 30-count (3 x 10) 40 mg strength capsules<br><strong>Drug Purpose</strong>: Treats severe cystic acne that has not responded to other treatments.<br><strong>Recall Reason</strong>: Failed dissolution testing; capsules may not dissolve properly, which may affect how the drug is released and absorbed.<br><strong>Recall Initiation Date</strong>: February 24, 2026​; this recall has not yet been classified.</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98477">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Metoprolol Succinate Extended‑Release Tablets</h3>
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<p><strong>Company</strong>: Teva Pharmaceuticals USA, Inc.<br><strong>Manufacturing Location</strong>: Not specified; Teva Pharmaceuticals is in Parsippany, New Jersey<br><strong>Scope</strong>: More than 100,000 bottles (100‑count and 1,000‑count), of 25 mg, 50 mg, 100 mg, and  200 mg strength tablets<br><strong>Drug Purpose</strong>: Beta blocker used to treat high blood pressure<br><strong>Recall Reason</strong>: Failed dissolution testing; tablets may not dissolve properly, which may reduce effectiveness.<br><strong>Recall Initiation Date</strong>: January 29, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98348">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Midodrine Hydrochloride Tablets</h3>
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<p><strong>Company</strong>: The Harvard Drug Group LLC<br><strong>Manufacturing Location</strong>: Not specified; Packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana<br><strong>Scope</strong>: 8,892 cartons of 5 mg strength, 50-tablet blister packs (5 x 10)<br><strong>Drug Purpose</strong>: Treats symptomatic orthostatic hypotension (chronic low blood pressure that causes dizziness or fainting upon standing).<br><strong>Recall Reason</strong>: Defective container: inadequately sealed blister packaging<br><strong>Recall Initiation Date</strong>: February 17, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=98456">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Nilotinib Capsules</h3>
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<p><strong>Company</strong>: Cipla USA, Inc.<br><strong>Manufacturing Location</strong>: Verna, Goa, India<br><strong>Scope</strong>: 271 cartons of 150 mg  strength capsules and 164 cartons of 200 mg strength capsules <br><strong>Drug Purpose</strong>: Treats a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia<br><strong>Recall Reason</strong>: An out-of-specification result was observed during long-term stability testing and visual inspection test at 6 months, potentially affecting quality or effectiveness. This was classified as a Class III recall, the least serious type of recall.<br><strong>Recall Initiation Date</strong>: February 18, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98452">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Temozolomide Capsules</h3>
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<p><strong>Company</strong>: Rising Pharmaceuticals, Inc.<br><strong>Manufacturing Location</strong>: Taiwan; manufactured for Rising Pharmaceuticals, Allendale, New Jersey<br><strong>Scope</strong>: 1,200 bottles of 5-capsule, 5 mg strength<br><strong>Drug Purpose</strong>: Oral chemotherapy used to treat glioblastoma and other brain tumors<br><strong>Recall Reason</strong>: An out-of-specification result was observed during long-term stability testing at 9 months; this could affect product effectiveness.<br><strong>Recall Initiation Date</strong>: March 3, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98523">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Wizcure’s Ophthalmic Products (eye drops, eye gels, and fluorescein strips)</h3>
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<p><strong>Company</strong>: Wizcure Pharmaa Private Limited<br><strong>Manufacturing Locations</strong>: Bhiwadi, India, and Ahmedabad, Gujarat, India, with these U.S. distributors: hi-Health in Scottsdale, Arizona; HUB Pharmaceuticals in Prescott, Arizona, and Vistamerica in Prescott, Arizona<br><strong>Scope</strong>: All lots of seven eye products: </p>
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<li>Vista Tears Eye Drops, Dry Eye Relief, Lubricant Drops 10 ml (5,760 cartons) </li>
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<li>Vista Gel Hypromellose Eye Drops Dry Eye Relief Lubricating Gel 10 ml (17,280 cartons)</li>
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<li>Vista Meibo Tears Propylene Glycol Eye Drops Advanced Dry Eye Relief Revitalizing Formula 10 ml (11,520 cartons)</li>
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<li>Vista Gonio Eye Lubricant Dry Eye Relief Hypromellose Ophthalmic Solution 15 ml (139,104 cartons)</li>
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<li>CHNaO Fluorescein Strips 100-count and 300-count(10,080 boxes)</li>
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<li>Bio Glo Fluorescein Sodium Ophthalmic Strips 300-count (50,400 boxes)</li>
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<li>BioGlo Fluorescein Sodium Ophthalmic Strips 100-count (184,320 containers)</li>
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<p><strong>Drug Purpose</strong>: Eye lubricant drops and gels in this recall are used to relieve dry eyes and are available to the consumer over-the-counter. Fluorescein ophthalmic strips are administered by eye care professionals to stain the eye surface to diagnose cornea injury or damage, or to use when fitting contact lenses.<br><strong>Recall Reason</strong>: Lack of assurance of sterility because of CGMP (current good manufacturing practices) violations.<br><strong>Recall Initiation Date</strong>: February 27, 2026.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98253">FDA Enforcement Report</a></p>
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<h2 class="wp-block-heading">Facility Inspections – FDA Warning Letters</h2>
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<h3 class="wp-block-heading">Novo Nordisk Inc.</h3>
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<p><strong>Type</strong>: Company Headquarters, U.S.<br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: March 5, 2026<br><strong>Facility Location</strong>: Plainsboro, New Jersey<br><strong>Date(s) of Inspections</strong>:  January 13 to February 7 of 2025; Inspection Report (Form FDA 483) issued at the close of the inspection.</p>
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<p><strong>FDA Warning</strong>: The FDA inspected Novo Nordisk’s compliance with “postmarketing adverse drug experiences” (PADE) reporting for its products and found serious violations.</p>
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<p>For example, Novo Nordisk failed to promptly report to the FDA or investigate the suicide / suicidal ideation of two patients taking semaglutide (Ozempic, Rybelsus, or Wegovy brand name). Another patient became disabled after experiencing a stroke while taking liraglutide (Victoza or Saxenda brand name), but because the patient didn’t attribute the stroke to liraglutide, it was rejected as a “serious and unexpected Adverse Drug Event (ADE)” and was not reported to the FDA.</p>
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<p>The FDA acknowledged Novo Nordisk correspondence dated March 3, 2025; April 11, 2025; May 2, 2025; June 6, 2025; July 11, 2025; September 19, 2025; October 31, 2025; and January 15, 2026. However, the FDA said the company’s explanations and remedial actions were inadequate.  </p>
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<p>Novo Nordisk’s contractor responsible for collecting adverse event reports was found to be excluding some events based on foreign regulatory rules rather than U.S. requirements.</p>
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<p>The warning letter stressed FDA’s concern with Novo Nordisk’s “ability to monitor the safety of your products, including through oversight of vendors with whom you contract to fulfill any of your ADE responsibilities.”</p>
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<p><strong>Essential Extras</strong>: Drug sponsors are required by law to collect and report adverse drug events to the FDA Adverse Event Reporting System (FAERS) database. Serious and unexpected ADEs (side effects not specifically listed on drug labels) are required to have “expedited reporting,” meaning they must be reported to the FDA within 15 calendar days. FDA monitors the FAERS and makes safety labeling updates, announcements, or in rare circumstances, market withdrawal of drugs for safety reasons. </p>
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<p>In a <a href="https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916514">press release</a>, Novo Nordisk stated that it has and will continue to take corrective and preventative actions to address all FDA observations.</p>
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<p>The warning has not affected the FDA’s evaluation of the risk of suicide associated with GLP-1s. In January 2026, the FDA <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp">announced</a> that after a comprehensive review, it did not find an increased risk of suicidal ideation and behavior associated with the use of GLP-1 RA medications and that the warning about the risk should be removed from the labeling of GLP-1 RA medications that currently include such language. </p>
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<p><strong>Types of Products Made</strong>: Products containing semaglutide, liraglutide, nedosiran sodium, and estradiol, and others. Brand-name drugs Ozempic, Wegovy, Rybelsus, Victoza, Saxenda, and others.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-717576-03052026">FDA Warning Letter<br></a>Read the warning letter for a complete description of violations.</p>
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<p><a href="https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916514">Novo Nordisk Company Statement</a> dated March 10, 2026<br><a href="https://www.novonordisk-us.com/patient-help/safety-reporting.html">Novo Nordisk Safety Reporting Portal</a> for Novo Nordisk products</p>
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