FDA Recalls and Warnings: Sterility Issues With Compounded GLP-1s, Foreign Pills in Generic Reglan Bottles

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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 involving compounded tirzepatide, semaglutide, tirzepatide-niacinamide, metoclopramide, NAD+, Quad Mix, semaglutide-cyanocobalamin, sermorelin acetate, tirzepatide-cyanocobalamin, Tri-Mix, and tretinoin cream.</p>
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<p>Three compounding pharmacies in this installment are recalling semaglutide and tirzepatide formulations that contain added vitamins or supplements. Some claim these supplements help reduce common side effects of the GLP-1 medications, boost energy, or improve muscle mass. Just as importantly, the addition of extra ingredients creates a formulation that differs from the FDA-approved branded products, which compounders may use as a legal justification to avoid producing an outright copy of a brand-name drug. </p>
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<p>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.</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">Compounded Semaglutide, Semaglutide/Cyanocobalamin, Tirzepatide, Tirzepatide/Cyanocobalamin, Tri-MIX (PAPAV/PHENTO/ALPROS), QUAD-MIX (PAPAV/PHENTO/ALPROS/TROP), Sermorelin Acetate</h3>
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<p><strong>Company</strong>: Carolina Infusion, LLC, a licensed <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/fda-drug-recalls-and-warnings-recalls-for-compounded-semaglutide-and-tirzepatide-wegovy-facility-warning-letters/">503A compounding</a> pharmacy<br><strong>Manufacturing Location</strong>: Ridgeland, South Carolina<br><strong>Scope</strong>: Patient-specific, single-dose syringes with volume based on each prescription; distributed nationwide in the United States; check the Enforcement Report for affected product strengths and lot numbers.<br><strong>Drug Purpose</strong>: Semaglutide treats 2 diabetes and obesity; it is the active ingredient in the brand-name drugs Ozempic and Wegovy. Tirzepatide treats type 2 diabetes and obesity; it is the active ingredient in the brand-name drugs Mounjaro and Zepbound. Semaglutide-cyanocobalamin and tirzepatide-cyanocobalamin are GLP-1 formulations with added B12 that is purported to help reduce side effects. Tri-Mix and Quad-Mix are custom injectable formulations used to treat symptoms of erectile dysfunction. Sermorelin stimulates growth hormone release and is no longer FDA-approved; it is used off-label to support adults with low growth hormone, fatigue, or muscle loss. Until 2008, sermorelin was sold under the brand name Geref to treat pediatric growth hormone deficiency, but it was voluntarily withdrawn in 2008 (not for safety reasons).<br><strong>Recall Reason</strong>: Lack of assurance of sterility related to formulation using bacteriostatic <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/water-pharmaceutical-use">water</a> (a sterile type of water used during production of injectable peptides and other compounded drugs) and sterility concerns related to processing equipment.<br><strong>Recall Initiation Date</strong>: September 10, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: The FDA inspected Carolina Infusion, LLC, August 8–August 15, 2026, and issued a Form <a href="https://www.fda.gov/media/194820/download">483</a> citing 10 items of concern, including inadequate sterilization procedures and inadequate endotoxin testing.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99867">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Compounded Sermorelin </h3>
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<p><strong>Company</strong>: Houston RX LLC, a licensed <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/fda-drug-recalls-and-warnings-recalls-for-compounded-semaglutide-and-tirzepatide-wegovy-facility-warning-letters/">503A compounding</a> pharmacy<br><strong>Manufacturing Location</strong>: Houston, Texas<br><strong>Scope</strong>: 7 vials of 1 mg/mL (10 mL of sermorelin per vial) of injectable solution<br><strong>Drug Purpose</strong>: Sermorelin stimulates growth hormone release. It is marketed as an off-label treatment to support adults with low growth hormone, fatigue, or muscle loss.<br><strong>Recall Reason</strong>: Lack of process control, meaning the drug could not be reliably manufactured to quality standards.<br><strong>Recall Initiation Date</strong>: September 25, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: Until 2008, sermorelin was sold under the brand name Geref to treat pediatric growth hormone deficiency, but the company voluntarily withdrew it from the market in 2008 (not due to safety concerns). Houston RX LLC's manufacturing facility was inspected between August 20–August 28, 2026, and the FDA issued a <a href="https://www.fda.gov/media/195122/download">Form 483</a> citing 14 items of concern, including sterility lapses and manufacturing procedure issues.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99990">FDA Enforcement Report </a></p>
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<h3 class="wp-block-heading">Compounded Tirzepatide Injection and Apothecary NAD+</h3>
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<p><strong>Company</strong>: Apothecary Pharma, LLC, a compounding pharmacy and registered <a href="https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities">503B</a> outsourcing facility<br><strong>Compounding Location</strong>: Cary, North Carolina<br><strong>Scope</strong>: 22 multi-dose 4 mL vials of 18 mg/mL compounded tirzepatide and 1 multi-dose vial of 200 mg/mL, 6 mL Apothecary NAD+<br><strong>Drug Purpose</strong>: Tirzepatide treats type 2 diabetes and obesity; it is the active ingredient in the brand-name drugs Mounjaro and Zepbound. Apothecary NAD+ (nicotinamide adenine dinucleotide) injection is marketed as a wellness supplement to help reverse the effects of aging by improving cellular repair, reducing inflammation, and supporting metabolic function.<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Recall Initiation Date</strong>: September 24, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: In December 2025, <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/compounding-pharmacies-cited-for-unsanitary-conditions-and-safety-lapses/">Apothecary Pharma LLC received</a> an FDA <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025">warning letter</a> after an unsatisfactory May 2025 manufacturing facility inspection.                    <br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99952">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Compounded Tirzepatide/ Niacinamide </h3>
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<p><strong>Company</strong>: Houston RX LLC, a licensed <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/fda-drug-recalls-and-warnings-recalls-for-compounded-semaglutide-and-tirzepatide-wegovy-facility-warning-letters/">503A compounding</a> pharmacy<br><strong>Manufacturing Location</strong>: Houston, Texas<br><strong>Scope</strong>: 64 vials of 20 mg/2 mg per mL, 2 mL vials (40 mg tirzepatide per vial) of injectable solution<br><strong>Drug Purpose</strong>: Tirzepatide treats type 2 diabetes and obesity; it is the active ingredient in the brand-name drugs Mounjaro and Zepbound. Niacinamide is Vitamin B3 and is added to the formulation as a dietary supplement to support metabolism and energy.<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Recall Initiation Date</strong>: September 25, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: The FDA inspected the Houston RX LLC manufacturing facility between August 20 – August 28, 2026, and issued an <a href="https://www.fda.gov/media/195122/download">FDA Form 483</a> citing 14 items of concern, including sterility lapses and manufacturing procedure issues.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99990">FDA Enforcement Report </a></p>
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<h3 class="wp-block-heading">Metoclopramide Tablets, 5 mg (generic for Reglan)</h3>
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<p><strong>Company</strong>: Teva Pharmaceuticals USA, Inc.<br><strong>Manufacturing Location</strong>: Zagreb, Croatia, by Pliva Hrvatska for Teva Pharmaceuticals, Parsippany, New Jersey <br><strong>Scope</strong>: 240,448 cartons of 100-count and 500-count bottles of 5 mg tablets<br><strong>Drug Purpose</strong>: Prescription acid reflux treatment for adults who do not respond to other medications; treats diabetic gastroparesis, a condition in which food moves slowly out of the stomach; also used to treat nausea.<br><strong>Recall Reason</strong>: Presence of foreign tablets or capsules<br><strong>Recall Initiation Date</strong>: September 29, 2026<br><strong>Recall Level:</strong> Class II<br><strong>Essential Extras</strong>: Manufacturing location obtained from the product <a href="https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e15905e0-e0f6-4c8b-ac19-59724d6c4bf0">drug label</a>.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=100013">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Metoclopramide Tablets, 5 mg (generic for Reglan)</h3>
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<p><strong>Company</strong>: American Health Packaging<br><strong>Manufacturing Location</strong>: Not specified; distributed by American Health Packaging, Columbus, Ohio; <a href="https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=998f1782-bbfa-469b-9fe1-c612e8588f70">product label</a> states it is from Teva Pharmaceuticals<br><strong>Scope</strong>: 5,363 100-count cartons of 10X10 blister packs of 5 mg tablets<br><strong>Drug Purpose</strong>: Prescription treatment for acid reflux in adults who do not respond to conventional reflux medications; treats diabetic gastroparesis, a condition where food moves slowly through the digestive tract; also used to treat nausea. <br><strong>Recall Reaso</strong>n: Presence of foreign tablets or capsules<br><strong>Recall Initiation Date:</strong> October 6, 2026<br><strong>Recall Level:</strong> Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=100100">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Tretinoin Cream, 0.05%</h3>
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<p><strong>Company</strong>: Sun Pharmaceuticals Industries<br><strong>Manufacturing Location</strong>: Brampton, Ontario, Canada, by Taro Pharmaceuticals Inc.<br><strong>Scope</strong>: One lot of 20g tubes and one lot of 45g tubes distributed and packaged by Taro Pharmaceuticals USA, Hawthorne, New York; one lot of 45 g tubes packaged by Pharmaceuticals RX, LLC, Memphis, Tennessee; the exact quantity of tubes in each lot is not specified.<br><strong>Drug Purpose</strong>: Prescription topical medication used to treat acne<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications; this could affect product shelf life and quality.<br><strong>Recall Initiation Date</strong>: September 25, 2026<br><strong>Recall Level</strong>: Class III<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99977">FDA Enforcement Report</a></p>
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