{"id":5459,"date":"2026-07-22T14:06:37","date_gmt":"2026-07-22T14:06:37","guid":{"rendered":"https:\/\/humanbodycalculator.com\/blogs\/?p=5459"},"modified":"2026-07-22T14:06:40","modified_gmt":"2026-07-22T14:06:40","slug":"fda-cetirizine-recall-contamination-signs-risks","status":"publish","type":"post","link":"https:\/\/humanbodycalculator.com\/blogs\/fda-cetirizine-recall-contamination-signs-risks\/","title":{"rendered":"FDA Cetirizine Recall: Contamination Signs &amp; Risks"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The FDA has recalled four lots of <strong>Cetirizine Hydrochloride Tablets USP 5 mg<\/strong> (a generic version of Zyrtec), made by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings. The recall covers bottles marked <strong>NDC 16571-401-10<\/strong> because some tablets may be cross-contaminated with <strong>ranitidine<\/strong>, a heartburn drug. If you&#8217;re sensitive to ranitidine, taking a contaminated tablet could trigger a serious allergic reaction. Here&#8217;s what you need to know:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>What&#8217;s affected:<\/strong> Four specific lot numbers of 100-count bottles, expiring 10\/2028<\/li>\n\n\n\n<li><strong>Why it matters:<\/strong> Possible severe allergic reaction in people sensitive to ranitidine<\/li>\n\n\n\n<li><strong>What to do:<\/strong> Check your bottle&#8217;s lot number and stop use if it matches<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What Happened With the Cetirizine Recall?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Unique Pharmaceutical Laboratories, a division of J.B. Chemicals &amp; Pharmaceuticals Ltd., announced a voluntary nationwide recall on <strong>July 18, 2026<\/strong>. The FDA <a href=\"https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/unique-pharmaceutical-laboratories-div-j-b-chemicals-pharmaceuticals-ltd-issues-voluntary-nationwide\" target=\"_blank\" rel=\"noopener\">posted the notice<\/a> on its site two days later. The product was distributed nationwide to wholesalers and retailers, so bottles could be sitting on pharmacy shelves or in home medicine cabinets across the country.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cetirizine is a widely used <strong>over-the-counter antihistamine<\/strong> for seasonal allergies, hay fever, and hives. Ranitidine, once sold under the brand name Zantac, is an acid reducer used for heartburn and ulcers. The two drugs treat completely different conditions, which is why finding one inside the other is a safety red flag rather than a labeling technicality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Signs of Contamination: How the Problem Was Caught<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The issue surfaced during routine dispensing, not through a lab audit. As <a href=\"https:\/\/www.news4jax.com\/news\/2026\/07\/21\/allergy-medication-recalled-nationwide-over-contamination-concerns\/\" target=\"_blank\" rel=\"noopener\">local news outlets reported<\/a>, a <strong>pharmacy technician noticed something unusual<\/strong> while counting tablets before filling a prescription.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Watch for these signs if you have an affected bottle:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Red or discolored dots<\/strong> on tablets that should be uniformly colored<\/li>\n\n\n\n<li><strong>Tablets that look mottled or blotchy<\/strong> compared to the rest of the bottle<\/li>\n\n\n\n<li><strong>Any tablet that looks visibly different<\/strong> from the others in the same container<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">If you notice any of these signs, don&#8217;t take the tablet. Set the bottle aside and follow the steps below.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Health Risks: Why Ranitidine Cross-Contamination Matters<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The danger isn&#8217;t cetirizine itself \u2014 it&#8217;s the risk to people who are <strong>hypersensitive to ranitidine<\/strong>. According to the FDA&#8217;s recall notice, ingesting a contaminated tablet could trigger a serious hypersensitivity reaction, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Low blood pressure (hypotension)<\/li>\n\n\n\n<li>Shortness of breath (dyspnea)<\/li>\n\n\n\n<li>Difficulty swallowing<\/li>\n\n\n\n<li>Swelling of the throat or face (edema)<\/li>\n\n\n\n<li>Widespread itching or hives<\/li>\n\n\n\n<li>Loss of consciousness<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Anaphylaxis, an emergency-level allergic reaction, is listed among the possible outcomes. As of the FDA&#8217;s July 20 update, <strong>no adverse events had been reported<\/strong> in connection with this recall. That&#8217;s a reassuring detail, but it doesn&#8217;t mean the risk isn&#8217;t real for people with a ranitidine sensitivity.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Which Products Are Affected<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Only bottles matching this exact NDC and lot number list are part of the recall:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>NDC<\/th><th>Lot Number<\/th><th>Expiration Date<\/th><th>Pack Size<\/th><\/tr><\/thead><tbody><tr><td>16571-401-10<\/td><td>GY825029<\/td><td>10\/2028<\/td><td>100-count HDPE bottle<\/td><\/tr><tr><td>16571-401-10<\/td><td>GY825030<\/td><td>10\/2028<\/td><td>100-count HDPE bottle<\/td><\/tr><tr><td>16571-401-10<\/td><td>GY825031<\/td><td>10\/2028<\/td><td>100-count HDPE bottle<\/td><\/tr><tr><td>16571-401-10<\/td><td>GY825032<\/td><td>10\/2028<\/td><td>100-count HDPE bottle<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Manufacturer:<\/strong> Unique Pharmaceutical Laboratories (a division of J.B. Chemicals &amp; Pharmaceuticals Ltd.) <strong>Distributed by:<\/strong> Rising Pharma Holdings Inc.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Other cetirizine products, including brand-name Zyrtec, are <strong>not<\/strong> part of this recall.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What to Do If You Have This Medication<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Check the NDC and lot number<\/strong> on your bottle against the table above.<\/li>\n\n\n\n<li><strong>Stop taking the tablets<\/strong> immediately if the numbers match.<\/li>\n\n\n\n<li><strong>Don&#8217;t throw the bottle away<\/strong> \u2014 you may need it to file a report or return.<\/li>\n\n\n\n<li><strong>Contact Rising Pharma Holdings<\/strong> with questions:\n<ul class=\"wp-block-list\">\n<li>Phone: 1-844-874-7464 (Monday\u2013Friday, 8 a.m.\u20135 p.m. EST)<\/li>\n\n\n\n<li>Email: pv@risingpharma.com or qa@risingpharma.com<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Call your doctor or pharmacist<\/strong> if you&#8217;ve already taken a tablet and feel unwell, especially if you have a known ranitidine sensitivity.<\/li>\n\n\n\n<li><strong>Seek emergency care<\/strong> for symptoms like throat swelling, trouble breathing, or fainting.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">How to Report a Problem or Side Effect<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA encourages anyone who experienced a reaction or found a discolored tablet to file a report through its <strong><a href=\"https:\/\/www.fda.gov\/safety\/medwatch-fda-safety-information-and-adverse-event-reporting-program\" target=\"_blank\" rel=\"noopener\">MedWatch Adverse Event Reporting program<\/a><\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Online at the MedWatch reporting page linked above<\/li>\n\n\n\n<li>By calling 1-800-332-1088 to request a mail-in form<\/li>\n\n\n\n<li>By fax at 1-800-FDA-0178<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">FAQ<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Is my cetirizine (Zyrtec) safe if it&#8217;s not on the recall list?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Yes. Only the four lot numbers listed above, tied to Unique Pharmaceutical Laboratories and NDC 16571-401-10, are affected. Brand-name Zyrtec and other generic manufacturers aren&#8217;t part of this recall.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Why is ranitidine dangerous in a cetirizine tablet?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ranitidine itself is an approved medication, but people with a hypersensitivity to it can have a serious allergic reaction if they take it unknowingly, especially in an unlabeled, unexpected form like an allergy pill.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What if I already took a tablet from a recalled lot and feel fine?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA notes no adverse events have been reported so far. Still, it&#8217;s worth stopping use, checking with a pharmacist, and watching for delayed symptoms like hives or swelling.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This recall affects a narrow slice of the cetirizine supply: four lot numbers from one manufacturer, tied to a packaging cross-contamination issue rather than a problem with cetirizine itself. Check your bottle&#8217;s NDC and lot number, stop use if it matches, and contact your pharmacist or Rising Pharma Holdings with questions.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Also Read: <a href=\"https:\/\/humanbodycalculator.com\/blogs\/coffee-and-heart-health-what-new-research-reveals\/\">Coffee and Heart Health: What New 2026 Research Reveals<\/a><\/p>\n<\/blockquote>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Disclaimer:<\/strong> The information in this article is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always talk to your doctor or pharmacist before making decisions about your medication.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has recalled four lots of Cetirizine Hydrochloride Tablets USP 5 mg (a generic version of Zyrtec), made by &#8230; <\/p>\n<p class=\"read-more-container\"><a title=\"FDA Cetirizine Recall: Contamination Signs &amp; Risks\" class=\"read-more button\" href=\"https:\/\/humanbodycalculator.com\/blogs\/fda-cetirizine-recall-contamination-signs-risks\/#more-5459\" aria-label=\"Read more about FDA Cetirizine Recall: Contamination Signs &amp; Risks\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":5461,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[243],"tags":[],"class_list":["post-5459","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicine-reviews-comparisons","resize-featured-image"],"_links":{"self":[{"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/posts\/5459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/comments?post=5459"}],"version-history":[{"count":2,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/posts\/5459\/revisions"}],"predecessor-version":[{"id":5462,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/posts\/5459\/revisions\/5462"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/media\/5461"}],"wp:attachment":[{"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/media?parent=5459"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/categories?post=5459"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/humanbodycalculator.com\/blogs\/wp-json\/wp\/v2\/tags?post=5459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}