Consumers urged to check their medicine bottles as officials warn of possible contamination

Millions of Americans use cetirizine every year to treat seasonal allergies, hives, and other allergy symptoms. Now, federal health officials are warning that some bottles of the common allergy medicine have been recalled because they may contain traces of a different drug that could cause a serious allergic reaction in some people.

The U.S. Food and Drug Administration (FDA) announced that Unique Pharmaceutical Laboratories is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg after an investigation found the tablets may have been cross-contaminated with ranitidine during manufacturing. The affected medicine was distributed nationwide by Rising Pharma Holdings Inc.

Cetirizine is the generic version of the allergy medicine Zyrtec. It helps relieve sneezing, itchy eyes, runny noses, and hives. Ranitidine, once widely sold under the brand name Zantac, is a different medication that was used to treat heartburn and stomach ulcers. Although reformulated versions of ranitidine have returned to the market in recent years, the two medicines are not supposed to be mixed together during manufacturing.

The FDA said the recall began after a pharmacy technician noticed unusual red spots and discoloration on some cetirizine tablets while filling a prescription. That observation led investigators to discover the possible contamination. So far, the company says it has not received any reports of people becoming sick because of the recalled medicine.

Health officials say the greatest risk is for people who are allergic or highly sensitive to ranitidine or its ingredients. In those cases, taking a contaminated tablet could trigger a severe allergic reaction called anaphylaxis. Symptoms may include swelling of the face or throat, trouble breathing, difficulty swallowing, hives, low blood pressure, or loss of consciousness. These reactions require immediate emergency medical care.

The recall applies only to Cetirizine Hydrochloride Tablets USP 5 mg packaged in 100-count bottles with National Drug Code (NDC) 16571-401-10. The affected lot numbers are GY825029, GY825030, GY825031, and GY825032, and all have expiration dates of October 2028. Other cetirizine products are not included in this recall.

For many families, especially those in communities with high rates of asthma and seasonal allergies, cetirizine is a medicine that is kept in the home year-round. Black, Latino, Native American, and some Asian American communities experience higher rates of asthma and environmental exposures that can worsen allergy symptoms. Because allergy medicines are used so often, experts say it is important for families to know when a recall affects products they may already have at home. The Centers for Disease Control and Prevention has reported that Black Americans continue to experience higher rates of asthma-related emergency department visits and deaths than White Americans, highlighting the importance of medication safety and access to accurate health information.

The FDA recommends that consumers stop using the recalled tablets if they have one of the affected bottles. People should contact their pharmacy or healthcare provider about obtaining a replacement or another allergy medication if needed. Anyone who develops symptoms after taking the medicine should seek medical attention right away.

Consumers with questions about the recall can contact Rising Pharma Holdings Inc. or report side effects through the FDA’s MedWatch safety reporting program. The FDA encourages patients and healthcare professionals to report any unexpected reactions because those reports help identify safety problems more quickly and protect the public.

Drug recalls like this one can be concerning, but public health experts say they are also evidence that safety monitoring systems are working. In this case, the problem was identified before any injuries had been reported, allowing regulators and the manufacturer to remove the affected products from pharmacies and alert consumers. Health officials encourage anyone who regularly takes prescription or over-the-counter medicines to check FDA recall notices from time to time and speak with a healthcare provider if they have questions about the medicines they use.