FDA Recalls and Warnings: Gas-X Contaminated With Coolant; More Generic Cymbalta Cancer Risks, Supplements Linked to Salmonella Outbreak 

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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 Amlodipine and Olmesartan Medoxomil, Duloxetine, Epinephrine, Erythromycin, Estradiol, Gas-X, Gas-X Extra Strength, Liraglutide, TNVitamins Ultrapotent Complete Green Superfood Moringa capsules, and Doctor’s Pride Complete Green Superfood Ultra Potent Moringa capsules. </p>
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<p>All drug recalls are nationwide “Class II” recalls, except for Gas-X Extra Strength (initiation date: June 4), which has not yet been classified. The moringa “superfood” supplements recall has been assigned a “Class I” level by the FDA due to serious potential health risks. 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"><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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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Warning Letters (Warning Letters Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></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-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Drug Imports Alerts Database</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></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">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">Amlodipine and Olmesartan Medoxomil Tablets (generic for Azor)</h3>
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<p><strong>Company</strong>: Ascend Laboratories, LLC<br><strong>Manufacturing Location</strong>: India by Alkem Laboratories Ltd.<br><strong>Scope</strong>: 15,696 bottles (30-count), 5mg/40mg strength<br><strong>Drug Purpose:</strong> A combination medication used to treat high blood pressure. It contains amlodipine, a calcium channel blocker, and olmesartan medoxomil, an angiotensin II receptor blocker (ARB), which work together to relax blood vessels and lower blood pressure.<br><strong>Recall Reason</strong>: Failed dissolution specification; the tablets may not dissolve properly, potentially reducing their effectiveness; the amount of active ingredient Olmesartan medoxomil was less than the required amount.<br><strong>Recall Initiation Date</strong>: May 5, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98874">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<br><strong>Manufacturing Location</strong>: Martorelles (Barcelona), Spain by Towa Pharmaceutical Europe S.L.<br><strong>Scope</strong>: 14,729 bottles (1000-count), 30 mg strength; 359,676 bottles (90-count and 1000-count), 60 mg strength<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"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: June 8, 2026<br><strong>Essential Extras</strong>: This is Breckenridge’s fourteenth recall event for duloxetine due to nitrosamine impurities since 2024. As part of a class action settlement, Breckenridge established the <a href="https://www.breckenridgefuturerefundprogram.com/frequently-asked-questions.aspx">Breckenridge Future Refund Program</a>, which reimburses consumers for out-of-pocket costs related to unused or returned Breckenridge duloxetine that is recalled after May 22, 2025.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99108">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Epinephrine Injection</h3>
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<p><strong>Company</strong>: Fresenius Kabi USA, LLC<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 898,050 single-dose vials (1 mg/mL strength)<br><strong>Drug Purpose</strong>: Used to treat severe allergic reactions, including anaphylaxis, and life-threatening low blood pressure (hypotension) associated with septic shock.<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications at the 18-month long-term stability testing; this could affect product quality and shelf life.<br><strong>Recall Initiation Date</strong>: May 14, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220430">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Erythromycin Tablets</h3>
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<p><strong>Company</strong>: Zydus Pharmaceuticals (USA) Inc.<br><strong>Manufacturing Location</strong>: Ahmedabad, India, by Zydus Lifesciences Ltd.<br><strong>Scope</strong>: 23,880 bottles (30-count and 100-count) of 250 mg strength; 10,992 bottles (30-count) of 500 mg strength<br><strong>Drug Purpose</strong>: Antibiotic used to treat bacterial infections<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"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: Initiated April 29, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?event=98870?Event=98870">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Estradiol Gel</h3>
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<p><strong>Company</strong>: ANI Pharmaceuticals, Inc., Baudette, MN<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 3,964 cartons (30 packets per carton) of 0.1%, 0.25 mg dose single-dose packets<br><strong>Drug Purpose</strong>: An estrogen replacement gel applied to the skin to treat menopause symptoms such as hot flashes and night sweats.<br><strong>Recall Reason</strong>: Defective container: packets were found to be either empty or partially full<br><strong>Recall Initiation Date</strong>: May 12, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98947">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Gas-X SoftGels (Simethicone)</h3>
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<p><strong>Company</strong>: Haleon US Holdings LLC, Warren, NJ<br><strong>Manufacturing Location:</strong> Not specified<br><strong>Scope</strong>: 285,330 blister cards (120-count) of 125 mg strength simethicone<br><strong>Drug Purpose:</strong> Over-the-counter treatment that helps relieve discomfort caused by gas, bloating, and fullness<br><strong>Recall Reason:</strong> Labeling issue: incomplete inactive ingredient information on the carton labeling<br><strong>Recall Initiation Date:</strong> May 11, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?event=98910?Event=98910">FDA Enforcement Report</a> </p>
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<h3 class="wp-block-heading">Gas-X Extra Strength SoftGels (Simethicone)</h3>
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<p><strong>Company</strong>: Haleon US Holdings LLC, Warren, NJ<br><strong>Manufacturing Location</strong>: India<br><strong>Scope</strong>: 35,883 boxes (72-count and 120-count) of 125 mg strength<br><strong>Drug Purpose</strong>: Over-the-counter treatment that helps relieve discomfort caused by gas, bloating, and fullness<br><strong>Recall Reason</strong>: The product may have been contaminated with diluted propylene glycol-based coolant during the packaging process. Reported health risks include nausea, vomiting, abdominal pain, and diarrhea.<br><strong>Recall Initiation Date</strong>: June 4, 2026<br><strong>Essential Extras</strong>: The FDA press release states that Gas-X Extra Strength Softgels are green capsules and found in packaging with a green band. Haleon has not yet received any reports of adverse events related to this recall, which affects four lots that expire in November 2028. Check the FDA Press Release for product pictures and more.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99125">FDA Enforcement Report</a> (recall not yet classified) and <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/haleon-issues-voluntary-nationwide-recall-gas-x-extra-strength-softgels-125mg-120-ct-and-72-ct">FDA Press Release</a></p>
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<h3 class="wp-block-heading">Liraglutide Injection, 6 mg/mL, 2-Pen and 3-Pen packs (bioequivalent for Victoza)</h3>
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<p><strong>Company</strong>: Lupin Pharmaceuticals Inc.<br><strong>Manufacturing Location</strong>: Nagpur, India by Lupin Ltd.<br><strong>Scope</strong>: 217,621 pen injectors<br><strong>Drug Purpose</strong>: GLP-1 medication that treats type 2 diabetes <br><strong>Recall Reason</strong>: Potential contamination due to the presence of particulate matter, described as a white, thread-like structure, in the cartridge.<br><strong>Recall Initiation Date</strong>: April 24, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219870">FDA Enforcement Report</a></p>
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<h2 class="wp-block-heading">Dietary Supplement Recalls</h2>
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<h3 class="wp-block-heading">TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules and Doctor’s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg</h3>
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<p><strong>Company</strong>: Total Nutrition Inc.<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 13,000 bottles (120-count)<br><strong>Supplement Purpose</strong>: A dietary supplement made from powdered moringa leaves. Moringa is a tropical tree native to India that is often promoted for its nutritional and health benefits.<br><strong>Recall Reason</strong>: Product may be contaminated with Salmonella. Most people infected with Salmonella experience diarrhea, fever, and stomach cramps, with symptoms usually within 72 hours after swallowing the bacteria. Although most people recover without treatment after 4 to 7 days, some people, such as young children, the elderly, or the immunocompromised, can become seriously ill.<br><strong>Recall Initiation Date</strong>: May 22, 2026<br><strong>Essential Extras</strong>: The recall was expanded on June 11, 2026, to include nine lots from Total Nutrition. The products were distributed nationally through the online platforms Amazon, Walmart, TikTok Shop, Target, and company websites. Total Nutrition Inc. has ceased distribution and sale of the product. Other brands containing moringa powder under a Class I recall include <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-moringa-leaf-powder-may-2026">Mogo moringa capsules</a>,<a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ambrosia-brands-llc-recalls-rosabella-moringa-capsules-because-possible-health-risk"> Ambrosia capsules</a>,<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=217602"> Healthy Truth</a> powder, <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=217193">Bulk & Organic LLC</a> powder, and<a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/why-not-natural-houston-texas-recalling-its-why-not-natural-organic-moringa-green-superfood-because"> Why Not Natural</a> capsules. The FDA and Centers for Disease Control (CDC) are conducting a joint investigation into Salmonella cases associated with moringa-containing dietary supplement products. As of May 27, the CDC reports <a href="https://www.cdc.gov/salmonella/outbreaks/supergreenssupplementpowders-1-26/">119 Salmonella cases.</a><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220737">FDA Enforcement Report</a> and <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/total-nutrition-inc-recalls-tnvitamins-and-doctors-pride-ultra-potent-complete-green-superfood">FDA Press Release</a> (May 26, 2026) and <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/total-nutrition-inc-expands-recall-tnvitamins-and-doctors-pride-ultra-potent-complete-green-0">FDA Press Release</a> (June 11, 2026)</p>
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