FDA Recalls and Warnings: Erectile Dysfunction Drug Ingredients Recalled Over Serious Quality Control Concerns

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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 drug recalls for sildenafil and tadalafil. This installment also features an FDA warning letter issued to Shoolin Pharma (the manufacturer of the recalled sildenafil and tadalafil) for violations at its manufacturing facility.</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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<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">Sildenafil Citrate and Tadalafil, for prescription compounding only</h3>
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<p><strong>Company</strong>: Shoolin Pharma Chem LLP<br><strong>Manufacturing Location</strong>: Indrad Village, Kadi, Mahesana, Gujarat, India<br><strong>Scope</strong>: 50KG of sildenafil, packaged in 1-gram bags or 1-kilogram bags; 41 kilograms of tadalafil products, packaged in 100-gram, 500-gram, or 1000-gram (1-kg) bags, distributed nationwide.<br><strong>Drug Purpose</strong>: Sildenafil citrate treats erectile dysfunction and is the active ingredient in brand-name Viagra. Tadalafil treats erectile dysfunction and is the active ingredient in brand-name Cialis. The recalled products are bulk active pharmaceutical ingredients intended solely for <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding">prescription compounding</a>.<br><strong>Recall Reason</strong>: Serious product quality concerns because of Current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.<br><strong>Essential Extras</strong>: The recalled products entered the U.S. and were sold to compounding pharmacies. It is not specified which compounding pharmacies purchased the products and whether they have already been distributed to consumers. If a consumer has purchased a sildenafil or tadalafil compounded product, they may wish to check with their pharmacy to confirm that the ingredients were not sourced from Shoolin Pharma. These products and others made at the Shoolin Pharma location are now on an import alert list, which allows them to be detained or denied entry into the United States. The FDA inspected the Shoolin Pharma facility in April 2026 and issued a <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoolin-pharma-chem-llp-734100-08182026">follow-up warning letter</a> on August 18. (See facility inspection warning letter summary below.)<br><strong>Recall Initiation Date</strong>: August 3, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99547">FDA Enforcement Report</a></p>
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<h2 class="wp-block-heading">Read The Inspection Facility Warning Letter to Shoolin Pharma</h2>
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<h3 class="wp-block-heading">Shoolin Pharma Chem LLC</h3>
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<p><strong>Type</strong>: Manufacturer of active pharmaceutical ingredients (APIs)<br><strong>FDA Department Issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: August 18, 2026<br><strong>Facility Location</strong>: Indrad Village, Kadi, Mahesana, Gujarat, India<br><strong>Date(s) of Inspections</strong>: April 13 to April 17, 2026<br><strong>FDA Warning</strong>: Inspectors observed unsanitary conditions and noticed a lack of basic quality oversight of the facility. Observations included unidentified residues, corroded equipment surfaces, leaking equipment, poorly stored product-transfer lines, and an employee wearing open-toed sandals near open processing equipment. </p>
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<p><a href="https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practice-cgmp">Current Good Manufacturing Practice (CGMP)</a> failures included inadequate cleaning and maintenance of shared equipment (used for more than one drug), missing raw laboratory data to support results reported on certificates of analysis, missing samples, and an ineffective quality unit. The agency found Shoolin’s response inadequate because it did not include detailed plans to correct these problems or an assessment of potential risks to previously distributed active pharmaceutical ingredient (API) batches. </p>
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<p>Because the FDA determined that medications compounded at the facility could be unsafe or ineffective, it recommended a <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99547">recall</a> of all Shoolin products currently in distribution in the United States. Shoolin began the recall on August 4, 2026. On August 11, the FDA placed the products on an <a href="https://www.accessdata.fda.gov/cms_ia/importalert_189.html">import alert</a>, meaning that all products originating from Shoolin may be detained or denied entry into the United States. The FDA recommended that Shoolin engage a consultant to conduct an audit of its operations for quality compliance. The company was required to respond to the FDA within 15 working days of receiving the August 18 warning letter with details of completed and planned corrective actions.</p>
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<p><strong>Types of Products Made At This Location</strong>: Active pharmaceutical ingredients (APIs), including sildenafil citrate and tadalafil (erectile dysfunction drug ingredients) and pregabalin (seizure drug ingredient), sold in bulk to <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding">compounding pharmacies</a>. In addition to manufacturing 14 active pharmaceutical ingredients, the company website says it also offers contract manufacturing services.<br><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoolin-pharma-chem-llp-734100-08182026">FDA Warning Letter<br></a>Read the warning letter for a complete description of violations along with selected photos taken at the facility depicting some of the documented observations.</p>
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