FDA Drug Recalls and Warnings: Blood Pressure Meds Tainted With Cancer-Causing Chemicals, Gabapentin Impurities 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’re highlighting recalls for Carbamazepine, Fasenra, Gabapentin, Levothyroxine, Norgestimate and Ethinyl Estradiol, Prazosin, Sucralfate, Tylenol, and Viorele. All of the recalls in this installment have been assigned a “Class II” level by the FDA (see below for definitions of types of recalls). 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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<p>This report is prepared using the most recent information posted in the<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm" target="_blank" rel="noreferrer noopener"> FDA’s Enforcement Reports Database</a> (for recalls), <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" target="_blank" rel="noreferrer noopener">Warning Letters Database</a> (for warning letters), and<a href="https://www.fda.gov/industry/actions-enforcement/import-alerts" target="_blank" rel="noreferrer noopener"> Drug Imports Alerts Database</a> (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.</p>
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<p>Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:</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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<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" target="_blank" rel="noreferrer noopener">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" target="_blank" rel="noreferrer noopener">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">Carbamazepine Extended-Release Tablets (generic for Tegretol)</h3>
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<p><strong>Company</strong>: American Health Packaging<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 360 cartons (30 400 mg tablets per carton, 3×10 unit dose cards)<br><strong>Drug Purpose</strong>: Prevents and treats seizures and nerve pain<br><strong>Recall Reason</strong>: Failed dissolution specifications; may not dissolve effectively after storage<br><strong>Recall Initiation Date</strong>: September 15, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97634" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Fasenra (Benralizumab) Injection</h3>
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<p><strong>Company</strong>: AstraZeneca Pharmaceuticals<br><strong>Manufacturing Location</strong>: Manufactured by AstraZeneca AB, Sweden; distributed by AstraZeneca Pharmaceuticals LP, Wilmington, DE<br><strong>Scope</strong>: 916 single-dose 30 mg/mL pre-filled syringes<br><strong>Drug Purpose</strong>: Treats severe types of asthma that do not respond to standard asthma treatments like inhaled corticosteroids<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Recall Initiation Date</strong>: October 8, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97760" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Gabapentin Capsules (generic for Neurontin)</h3>
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<p><strong>Company</strong>: Harvard Drug Group; packaged and distributed by Major Pharmaceuticals<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: Quantity not specified, but affects multiple lots of 100-capsule and 10-capsule blister packs of 100 mg capsules<br><strong>Drug Purpose</strong>: Treats nerve pain and epilepsy<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications; this means the drug may contain unintended chemical substances or has broken down from its original form<br><strong>Recall Initiation Date:</strong> October 10, 2025<br><strong>Essential Extras</strong>: In June 2025, Harvard Drug Group initiated a separate recall for 100 mg gabapentin capsules packaged by Major Pharmaceuticals due to inadequately sealed blister packs.</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97777" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a> (October) and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97087" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a> (June 2025 for defective blister packs)</p>
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<h3 class="wp-block-heading">Levothyroxine Sodium Tablets (generic for Synthroid)</h3>
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<p><strong>Company</strong>: Accord Healthcare<br><strong>Manufacturing Location</strong>: Intas Pharmaceuticals Limited, Selaqui, India<br><strong>Scope</strong>: 54,432 bottles of 90-count 88 mcg tablets<br><strong>Drug Purpose</strong>: Treats hypothyroidism<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 16, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=97613" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Norgestimate and Ethinyl Estradiol Tablets</h3>
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<p><strong>Company</strong>: AvKARE<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 2,192 cartons (three 28-tablet blister cards per carton)<br><strong>Drug Purpose</strong>: Oral contraceptive<br><strong>Recall Reason</strong>: Failed content uniformity specifications, which means the active pharmaceutical ingredient was not evenly distributed within dosage units<br><strong>Recall Initiation Date</strong>: September 2, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97542" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Prazosin Hydrochloride Capsules (generic for Minipress)</h3>
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<p><strong>Company</strong>: Teva Pharmaceuticals USA, North Wales, PA<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: Over 580,000 bottles; multiple lots of 1 mg, 2 mg, and 5 mg capsules<br><strong>Drug Purpose</strong>: Alpha blocker treatment for high blood pressure; also used off-label for post-traumatic stress disorder (PTSD)-related nightmares<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications" target="_blank" rel="noreferrer noopener"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: October 7, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97755" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Prazosin Hydrochloride Capsules (generic for Minipress)</h3>
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<p><strong>Company</strong>: Amerisource Health Services LLC; American Health Packaging (packager)<br><strong>Manufacturing Location</strong>: Not specified; product was manufactured by Teva and packaged and distributed by American Health Packaging<br><strong>Scope</strong>: More than 7,000 cartons of 1mg, 2mg, and 5 mg capsules<br><strong>Drug Purpose</strong>: Alpha blocker treatment for high blood pressure; also used off-label for post-traumatic stress disorder (PTSD)-related nightmares<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications" target="_blank" rel="noreferrer noopener"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: October 16, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97826" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Sucralfate Tablets (generic for Carafate)</h3>
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<p><strong>Company</strong>: Amerisource Health; distributed by American Health Packaging<br><strong>Manufacturing Location:</strong> Manufactured by Nostrum Laboratories in Kansas City, MO Scope: 27,868 blister packs (100-count 1 gram tablets)<br><strong>Drug Purpose</strong>: Prevents and treats peptic (stomach) ulcers<br><strong>Recall Reason</strong>:  Due to Nostrum’s bankruptcy, quality cannot be assured<br><strong>Recall Initiation Date</strong>: October 9, 2025<br><strong>Essential Extras</strong>: In July 2025, Nostrum announced its company closure and discontinuation of quality activities. It also announced its recall of 1-gram sucralfate.</p>
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<p><strong>Link</strong>:<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97794" target="_blank" rel="noreferrer noopener"> FDA Enforcement Report</a> and<a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-sucralfate-tablets-usp-1-gram-within" target="_blank" rel="noreferrer noopener"> Nostrum Laboratories FDA Press Release</a></p>
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<h3 class="wp-block-heading">Tylenol (Acetaminophen 500 mg)</h3>
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<p><strong>Company</strong>: Kenvue Brands, LLC<br><strong>Manufacturing Location</strong>: Not specified; distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division<br><strong>Scope</strong>: 3,816 bottles of 24-count 500mg strength caplets<br><strong>Drug Purpose</strong>: Pain reliever and fever reducer<br><strong>Recall Reason</strong>: Defective Container<br><strong>Recall Initiation Date</strong>: October 21, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97850" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Viorele (Desogestrel and Ethinyl Estradiol Tablets)</h3>
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<p><strong>Company</strong>: Glenmark Pharmaceuticals<br><strong>Manufacturing Location:</strong> Glenmark Pharmaceuticals Limited, Goa, India<br><strong>Scope</strong>: 26,928 packs (three 28-tablet blisters per pack)<br><strong>Drug Purpose</strong>: Oral contraceptive<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications; this means the drug may contain unintended chemical substances or has broken down from its original form<br><strong>Recall Initiation Date</strong>: September 3, 2025</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97547" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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