FDA Drug Recalls and Warnings: Sterility Issues in Compounded GLP-1s, Antidepressants With Elevated Cancer-Linked Chemicals 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 Bromocriptine Mesylate, Bupropion, Carbidopa/Levodopa/Entacapone combination tablets, Chlorpromazine, Clomipramine, Desipramine, Duloxetine, Niacin Extended Release, compounded Semaglutide, Tirzepatide, and Retatrutide products, and Walgreens Saline Nasal Spray.</p>
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<p>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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<li><strong>Recalls (Enforcement Reports Database)</strong></li>
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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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<li><strong>Warning Letters (Warning Letters Database)</strong></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.</p>
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<li><strong>Drug Imports Alerts Database</strong></li>
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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">Bromocriptine Mesylate Capsules (generic for Parlodel)</h3>
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<p><strong>Company</strong>: Zydus Pharmaceuticals<br><strong>Manufacturing Location</strong>: Zydus Lifesciences, Ahmedabad, India<br><strong>Scope</strong>: 36,624 bottles (5 mg, 30-count)<br><strong>Drug Purpose</strong>: Treats hyperprolactinemia, or high levels of the hormone prolactin, which can be caused by a benign pituitary tumor.<br><strong>Recall Reason</strong>: Failed impurities and degradation tests<br><strong>Recall Initiation Date</strong>: October 23, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97847" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Bupropion Hydrochloride Extended-Release Tablets XL (generic for Wellbutrin)</h3>
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<p><strong>Company</strong>: Graviti Pharmaceuticals Private Limited; distributed and packaged by Rising Pharma<br><strong>Manufacturing Location</strong>: Sangareddy, Telangana, India<br><strong>Scope</strong>: 46,512 bottles (300 mg, 30-count)<br><strong>Drug Purpose</strong>: Antidepressant<br><strong>Recall Reason</strong>: Failed tablet/capsule specifications, which means the tablet failed quality control tests.<br><strong>Recall Initiation Date</strong>: September 24, 2025<br><strong>Link</strong>: <a href="http://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97629" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Carbidopa, Levodopa, Entacapone (Combination) Tablets</h3>
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<p><strong>Company</strong>: Rising Pharma Holdings, Inc.<br><strong>Manufacturing Location</strong>: Suven Pharmaceuticals Limited, Pashamylaram, Telangana, India<br><strong>Scope</strong>: 2,064 100-count bottles of 25 mg/100 mg/200 mg film-coated tablets<br><strong>Drug Purpose</strong>: Treats Parkinson’s disease<br><strong>Recall Reason</strong>: Product mix-up: A complaint indicated that sealed bottles labeled as Carbidopa/Levodopa/Entacapone 25 mg/100 mg/200 mg actually contained the higher-strength 37.5 mg/150 mg/200 mg tablets.<br><strong>Recall Initiation Date</strong>: October 7, 2025<br>Link: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97768" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Chlorpromazine Hydrochloride Tablets (formerly branded as Thorazine)</h3>
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<p><strong>Company</strong>: Major Pharmaceuticals<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 2,064 blister packs of 25 mg, 50 Tablets per blister package<br><strong>Drug Purpose</strong>: Antipsychotic that treats schizophrenia and other mood disorders<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> September 12, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97584" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Clomipramine Hydrochloride Capsules (generic for Anafranil)</h3>
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<p><strong>Company</strong>: Zydus Pharmaceuticals (manufactured for Northstar Rx)<br><strong>Manufacturing Location</strong>: Zydus Lifesciences Ltd., Ahmedabad, India<br><strong>Scope</strong>: 25mg, 50mg, and 75mg capsules; quantity not specified<br><strong>Drug Purpose</strong>: Treats obsessive compulsive disorder (OCD)<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 22, 2025<br><strong>Link</strong>:<a href="https://www.accessdata.fda.gov/scripts/ires/?Event=97856" target="_blank" rel="noreferrer noopener"> FDA Recall Announcement</a></p>
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<h3 class="wp-block-heading">Desipramine HCL Tablets (generic for Norpramin)</h3>
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<p><strong>Company</strong>: Heritage Pharmaceuticals (now doing business as Avet Pharmaceuticals)<br><strong>Manufacturing Location</strong>: USV Private Ltd., Daman, India<br><strong>Scope</strong>: 33,663 bottles of strengths ranging from 10 mg to 150 mg (50 and 100-count)<br><strong>Drug Purpose</strong>: Tricyclic antidepressant<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 6, 2025<br><strong>Link</strong>:<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97770" target="_blank" rel="noreferrer noopener"> FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Duloxetine Delayed-Release Capsules (generic for Cymbalta)</h3>
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<p><strong>Company</strong>: Breckenridge Pharmaceutical, Inc.<br><strong>Manufacturing Location</strong>: Towa Pharmaceutical Europe, Martorelles (Barcelona), Spain<br><strong>Scope</strong>: 172,263 bottles of 60mg strength capsules (90-count and 1000-count)<br><strong>Drug Purpose</strong>: Antidepressant<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>: Initiated October 9, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97797" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Niacin Extended-Release Tablets</h3>
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<p><strong>Company</strong>: Lannett Company<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 46,848 bottles of 1,000 mg Tablets (90-count)<br><strong>Drug Purpose</strong>: Used as a lipid-lowering agent to manage cholesterol levels<br><strong>Recall Reason</strong>: Failed dissolution specifications; may not dissolve effectively after storage<br><strong>Recall Initiation Date:</strong> October 10, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97778" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Compounded Semaglutide and Tirzepatide</h3>
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<p><strong>Company</strong>: ProRx LLC (licensed compounding pharmacy)<br><strong>Manufacturing Location</strong>: Exton, Pennsylvania<br><strong>Scope</strong>: More than 36,000 multidose vials of semaglutide in various strengths; 2,761 3 mL multidose vials of tirzepatide; both distributed in Texas and Utah<br><strong>Drug Purpose</strong>: Treats type 2 diabetes and obesity<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Essential Extras:</strong> Earlier this year, ProRx received a <a href="https://medshadow.org/fda-recalls-for-compounded-semaglutide-and-tirzepatide-wegovy/" target="_blank" rel="noreferrer noopener">warning letter</a> from the FDA after a facility inspection revealed multiple Current Good Manufacturing Practice (CGMP) violations.<br><strong>Recall Initiation Date</strong>: October 15, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97808" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Compounded Semaglutide, Semaglutide with B12, Tirzepatide, Retatrutide, and Other Injectables</h3>
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<p><strong>Company</strong>: GenoGenix, LLC (licensed compounding pharmacy); some products labeled as manufactured for Synergy Wellness<br><strong>Manufacturing Location</strong>: Boca Raton, FL<br><strong>Scope</strong>: 10 mL vials of Tirzepatide 60 mg/10 mL for injection; 10 mL multi-dose vials of Semaglutide 20 mg/mL; Semaglutide with Vitamin B12 for injection (all strengths); 54 additional compounded sterile injectable products, including amino-acid blends, vitamin D-3, Lipo MIC + B12 Methylcobalamin, and other vitamin/“wellness” injections<br><strong>Drug Purpose</strong>: Treats type 2 diabetes and obesity; vitamins used for a variety of health reasons<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Essential Extras:</strong> Retatrutide, included among the products, is an experimental Eli Lilly obesity drug still in clinical trials. FDA explicitly warns that Retatrutide <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" target="_blank" rel="noreferrer noopener">cannot be legally compounded </a>because it is not on the FDA’s compounding bulks list and has no approved formulation.<br><strong>Recall Initiation Date</strong>: July 30, 2025 (FDA did not classify this recall until October 21, 2025)<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97369" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Walgreens Saline Nasal Spray with Xylitol</h3>
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<p><strong>Company</strong>: Medical Products Laboratories (distributed by Walgreens)<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 41,328 bottles, 1.5 oz (45mL)<br><strong>Drug Purpose</strong>: Nasal saline spray for congestion relief<br><strong>Recall Reason</strong>: Microbial contamination with Pseudomonas lactis, a type of bacteria<br><strong>Recall Initiation Date</strong>: November 12, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97949" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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