Over-the-Counter Allergy Medication Recalled Nationwide Due to Cross-Contamination Risk

Select lots of a popular over-the-counter allergy medication distributed nationwide are being voluntarily recalled following concerns over potential cross-contamination with an unlisted drug ingredient.

The U.S. Food and Drug Administration (FDA) announced that Unique Pharmaceutical Laboratories has issued a voluntary recall for four lots of Cetirizine Hydrochloride Tablets USP, 5 mg. Distributed by Rising Pharma Holdings Inc., the antihistamine was packaged and sold in 100-count bottles across wholesalers and retail stores nationwide.

Reason for the Recall

The nationwide market withdrawal was initiated after a pharmacy technician identified a discrepancy while counting tablets prior to dispensing. Further inspection revealed that some tablets had discolored red dots, leading to the discovery that select lots were contaminated with ranitidine—a medication commonly used to treat heartburn and acid reflux.

While no adverse health incidents or reactions have been reported to date, health officials warn that consuming tablets contaminated with ranitidine poses serious risks for individuals with a hypersensitivity or severe allergy to the ingredient. Potential health complications could include severe allergic reactions, swelling of the throat or face, difficulty breathing, low blood pressure, or life-threatening anaphylaxis.

Affected Product Details

Consumers, pharmacies, and retailers holding bottle inventory are advised to check the product labeling for the following details:

What Consumers Should Do

• Check Packaging: Review lot numbers printed on any 100-count bottles of 5 mg cetirizine tablets.

• Discontinue Use: Individuals in possession of recalled lots should immediately stop using the product.

• Contact Distributor: Questions regarding product returns can be directed to Rising Pharma Holdings Inc. at 1-844-874-7464 (Monday–Friday, 8:00 AM – 5:00 PM EST) or via email at [email protected].

• Consult Healthcare Providers: Consumers who suspect they have experienced an adverse reaction should seek immediate medical attention and report issues through the FDA’s MedWatch program.