FDA Drug Recalls and Warnings: Compounding Pharmacies Cited for Unsanitary Conditions and Safety Lapses

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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. This installment features facility inspection warning letters addressed to three compounding pharmacies: Apothecary Pharma, LLC, GenoGenix, and MedisourceRx (owned by the Hims & Hers telehealth company).</p>
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<p>The three facilities warned are <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding">compounding pharmacies</a> registered with the FDA as “503B outsourcing facilities.” These pharmacies can manufacture and distribute large batches of drugs for sale to hospitals and clinics, and may also produce drugs to meet demand during a national drug shortage. While drugs produced by 503B registered outsourcing compounding pharmacies are not considered FDA-approved, they must follow Current Good Manufacturing Practice (CGMP) and use ingredients sourced from FDA-registered suppliers.</p>
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<p>A separate category, known as 503A compounding pharmacies, is regulated primarily by state boards of pharmacy. These pharmacies prepare patient-specific prescriptions and must follow <a href="https://www.usp.org/compounding/legal-considerations">U.S. Pharmacopeia (USP) quality standards</a>. </p>
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<p>Telehealth websites and “medical spa”- type healthcare providers often contract with 503B and 503A pharmacies to produce the products they sell. Telehealth prescribing, combined with rising demand for compounded drugs, has been linked to <a href="https://medshadow.org/drug-updates-recalls/drug-safety/teleprescribing-risks-hims-hers/">drug safety concerns</a>. Ingredients sourced from unsafe or counterfeit suppliers, production quality lapses, and gaps in patient education about side effects and proper use have led to <a href="https://medshadow.org/fda-recalls-for-compounded-semaglutide-and-tirzepatide-wegovy/">recalls</a> and patient harm.</p>
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<h2 class="wp-block-heading">How to Read This Report</h2>
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<p><span style="box-sizing: border-box; margin: 0px; padding: 0px;">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"> 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">Warning Letters Database</a> (for warning letters), and<a href="https://www.fda.gov/industry/actions-enforcement/import-alerts" target="_blank"> Drug Imports Alerts Database</a> (for drug importers subject to import bans).</span> 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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<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">Facility Inspections – FDA Warning Letters</h2>
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<h3 class="wp-block-heading">Company: Apothecary Pharma, LLC</h3>
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<p><strong>Type</strong>: Compounding pharmacy and <a href="https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities">FDA-registered outsourcing facility</a><br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: December 1, 2025; posted on the FDA website March 17, 2026<br><strong>Facility Location</strong>: Cary, North Carolina<br><strong>Date(s) of Inspections</strong>: May 12 - May 15, 2025; Inspection report (<a href="https://www.fda.gov/media/186741/download">Form FDA 483</a>) issued on May 15, 2025<br><strong>Types of Products Made</strong>: Sterile and non-sterile compounded medications, including compounded GLP-1 drugs, as well as private-label products for healthcare providers and clients, such as medical spas.</p>
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<p><strong>Warning</strong>: The facility had multiple 503B and “Current Good Manufacturing Process” (CGMP) violations. Some products, including tirzepatide and semaglutide injections, lacked essential labeling information, such as active and inactive ingredients, strength, dose, and administration instructions. Procedures for reporting adverse events were inadequate.</p>
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<p>Current Good Manufacturing Practice (CGMP) failures also included weak oversight of quality units, poor equipment and room-cleaning systems, inadequate smoke studies, and incomplete batch records. Insanitary conditions violations included poor gowning and glove practices of workers and rusty or hard-to-clean equipment in aseptic areas.</p>
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<p>The FDA found that some of Apothecary’s corrective actions appeared adequate but lacked supporting documentation. Some of the corrective actions were deficient. Apothecary Pharma was instructed to respond to the Office of Compounding Quality and Compliance within 15 working days, explaining the specific steps taken to address any violations.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025">FDA Warning Letter</a><br>Read the warning letter for a complete description of violations </p>
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<h3 class="wp-block-heading">Company: GenoGenix</h3>
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<p><strong>Type</strong>: Compounding pharmacy and <a href="https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities">FDA-registered outsourcing facility<br></a><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: January 20, 2026; posted on the FDA website March 3, 2026<br><strong>Facility Location</strong>: Boca Raton, Florida<br><strong>Date(s) of Inspections</strong>: July 14 - July 18, 2025; Inspection report (<a href="https://www.fda.gov/media/188559/download">Form FDA 483</a>) issued on July 18, 2025<br><strong>Types of Products Made</strong>: Sterile injectable compounded products; repackaged GLP-1 drugs; nasal sprays; capsules; and other peptide and vitamin products sold to doctors’ offices, med spas, clinics, and other businesses, along with various nutraceutical and skincare products.<br><strong>Warning</strong>: The facility had multiple serious 503B and Current Good Manufacturing Practice (CGMP) violations, including failures in sterile-product labeling; inadequate adverse event reporting procedures; manufacturing under insanitary conditions; weak quality unit oversight; poor investigation of deviations; subpotent drugs; insufficient laboratory and batch record controls; and inadequate training and contamination-prevention systems.</p>
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<p>Before the FDA stepped in, GenoGenix was producing ineligible drugs (drugs not allowed under FDA rules for 503B outsourcing facilities), including peptide injectables such as 5-Amino-1MQ and NAD+, using ingredients not on the <a href="https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding">FDA’s approved bulk drug substances list</a>. One NAD+ product was associated with elevated bacterial endotoxin levels, resulting in adverse events. Three patients developed low blood pressure, uncontrollable shaking, shivering, and body aches shortly after or during administration of a product from the same vial.</p>
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<p>The FDA found GenoGenix’s corrective and preventive actions to be inadequate and/or lacking supporting documentation. The agency noted that the firm had ceased drug production and distribution and initiated a voluntary recall on July 30, 2025, for products with potential microbial contamination. GenoGenix was instructed to respond to the Office of Compounding Quality and Compliance within 15 working days, either detailing the steps taken to address the violations or indicating that it does not intend to resume drug production.</p>
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<p><strong>Essential Extras</strong>: In July 2025, GenoGenix initiated a large <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97369">recall</a> of semaglutide, tirzepatide, retatrutide, GLP-1 vitamin combination products, and 54 additional compounded injectables, including vitamins and vitamin blends like Amino Blend, Vitamin D-3, Lipo MIC +B12 Methylcobalamin, and more, due to product sterility problems. As of the date of the warning letter, GenoGenix had ceased drug production while it works to correct the violations at its facility. Currently, the <a href="https://shop.genogenix.com/">GenoGenix </a>website, which requires a business customer log-in, says it sells nutraceuticals and skin care products. It is not known which businesses purchase and sell GenoGenix products or what specific products it still makes or distributes.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genogenix-llc-718739-01202026">FDA Warning Letter</a><br>Read the warning letter for a complete description of violations.</p>
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<h3 class="wp-block-heading">Company: MedisourceRx</h3>
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<p><strong>Type</strong>: Compounding pharmacy and <a href="https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities">FDA-registered outsourcing facility<br></a><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: December 12, 2025; posted on the FDA website February 24, 2026<br><strong>Facility Location</strong>: Los Alamitos, California<br><strong>Date(s) of Inspections</strong>: May 27, 2025 - June 10, 2025; Inspection Report <a href="https://www.fda.gov/media/187955/download?attachment">Form FDA 483</a> issued June 10, 2025<br><strong>Types of Products Made</strong>: Sterile compounded drug products, including semaglutide injection and hormone health treatments sold to Hims & Hers Telehealth customers (see “Essential Extras” below)<br><strong>FDA Warning</strong>: MedisourceRx failed to submit adverse event reports to the FDA within the required timeframe. According to the inspection report, one case involved a patient with severe gastrointestinal issues and a 3-night hospital stay after taking a compounded semaglutide injection. The company failed to report this serious adverse event within the required 15 days. </p>
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<p>Although the FDA acknowledged that additional adverse event reports received prior to its inspection were submitted retroactively, the agency still deemed adverse event reporting procedures deficient. The facility was instructed to revise its adverse event reporting procedures to include clear definitions and timelines. MediSourceRx was instructed to respond to the Office of Compounding Quality and Compliance within 15 working days, explaining the specific steps taken to address the violations.</p>
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<p><strong>Essential Extras</strong>: An additional violation noted in the Form 483 FDA inspection report but corrected before the warning letter was issued was for “vermin infestation” due to the observation of a “live spider in the production area” and “a dead cricket in the middle of the incubator room.”</p>
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<p>Telehealth company Hims & Hers acquired MedisourceRx in September 2024, allowing it to bring much of its drug compounding operations in-house. Ozempic and Wegovy maker Novo Nordisk <a href="https://www.pharmacytimes.com/view/novo-nordisk-drops-hims-hers-inside-the-compounded-glp-1-crisis">terminated its collaboration</a> with Hims and Hers in July 2025, citing illegal compounding and deceptive marketing. In March 2026, Hims & Hers <a href="https://thehill.com/policy/healthcare/5775413-novo-nordisk-hims-hers-collaboration/">partnered</a> again with Novo Nordisk, this time promoting only the branded semaglutide products Ozempic and Wegovy. MediSourceRx continues to supply Hims & Hers with other compounded drugs, including tailored hormone therapies and limited sterile injectables.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medisourcerx-717970-12122025">FDA Warning Letter</a>  <br>Read the warning letter for a complete description of violations.</p>
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