FDA Issues Nationwide Recall of Generic Zyrtec Antihistamine Tablets
Generic Zyrtec tablets recalled nationwide over contamination concerns with heartburn drug ranitidine.
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The Food and Drug Administration (FDA) has announced a voluntary nationwide recall of a generic version of the popular allergy medication Zyrtec. The recall, initiated on July 18, 2026, involves cetirizine hydrochloride tablets due to potential contamination with ranitidine, a heartburn drug that poses serious health risks to sensitive individuals.
Details of the FDA Recall and Affected Products
Unique Pharmaceutical Laboratories, the manufacturer behind the generic antihistamine, reported the issue after a pharmacy technician noticed red dots and discoloration on some tablets during routine counting and bottling. This observation prompted an FDA investigation, which confirmed cross-contamination with ranitidine in specific batches of cetirizine hydrochloride 5 mg tablets.
The recalled products were distributed by Rising Pharma Holdings Inc. across the United States in 100-tablet bottles. The recall specifically affects four lot numbers set to expire in October 2028:
- GY825029
- GY825030
- GY825031
- GY825032
Consumers are urged to check the lot numbers of their medication and avoid using the affected products.
Health Risks and Safety Precautions
Ranitidine, the contaminant found in the recalled tablets, has been linked to serious health risks, especially for those with hypersensitivity or allergies to this ingredient. Exposure to ranitidine can trigger symptoms such as hypotension (low blood pressure), shortness of breath, difficulty swallowing, and in severe cases, loss of consciousness or other life-threatening reactions.
Although no adverse events have been reported so far related to this contamination, the FDA stresses the importance of vigilance. Patients who suspect they may have taken the affected medication and experience unusual symptoms should contact their healthcare provider immediately.
Return and Replacement Process for Consumers
Rising Pharma Holdings has proactively informed pharmacies, retailers, and distributors about the recall and is arranging for the collection and return of all affected medications. Customers who have purchased the recalled products can reach out directly to Rising Pharma Holdings for guidance on returning the medication and obtaining replacements.
Contact methods for consumers include:
- Phone: 1-844-874-7464
- Email: pv@risingpharma.com or qa@risingpharma.com
Healthcare providers recommend patients consult their doctors or pharmacists for alternative allergy treatments during this recall period.
What This Means for Allergy Patients in North Carolina
With allergy season underway in Wayne County, Duplin County, and surrounding areas, many residents rely on cetirizine-based medications like generic Zyrtec for symptom relief. This recall may impact access to affordable antihistamines in local pharmacies temporarily, prompting patients to seek alternatives or brand-name versions until the issue is resolved.
Local healthcare providers advise patients to verify their medication lot numbers and report any suspicious packaging or discoloration. Additionally, patients experiencing allergy symptoms should not abruptly stop medication without consulting a medical professional.
Consumers and healthcare providers alike are encouraged to stay informed through FDA updates and local news outlets as the recall progresses.
