SerpApi.Org
Millions of Americans are being urged to check their medicine cabinets for a common allergy medication over fears it may be contaminated with a potentially life-threatening ingredient.
Unique Pharmaceutical Laboratories has recalled its over-the-counter cetirizine hydrochloride tablets after tests showed they may contain ranitidine, commonly known as the brand name Zantac, a medication used to reduce stomach acid.
Ranitidine was banned in the US in 2020 over fears it contained the cancer-linked chemical NDMA, but was re-approved in 2025 after it was reformulated.
Health officials warned it could trigger a life-threatening 'serious adverse reaction' in people with a sensitivity to the ingredients used to make ranitidine tablets, including low blood pressure, swelling and loss of consciousness.
The recalled cetirizine hydrochloride tablets, commonly known as the brand name Zyrtec, were sold nationwide in 100-tablet white plastic bottles, each containing five milligrams of cetirizine. They were available at major retailers.
Unique Pharmaceuticals said it had received no reports of illnesses linked to the medications to date.
But anyone who has the medication has been urged not to consume it. Officials at the company are organizing a return of all affected products.
People have been told to contact their physician if they have suffered any complications after taking or using the drug.
Nearly 90 million adults in the US, or one in three, suffer from seasonal allergies, which is when the immune system overreacts to pollen leading to symptoms such as sneezing, coughing and watery eyes.
And many of those sufferers reach for over-the-counter remedies such as cetirizine.
Cetirizine is an antihistamine that treats allergy symptoms by helping to calm the immune system.
In the recall, the manufacturer, based in India, has issued an alert over four lots of its drug: GY825029, GY825030, GY825031 and GY825032. A full list of the recalled products is available on the FDA website.
These are all set to expire by October 2028.
Investigators said the issue was only found after a pharmacy technician noticed discrepancies while counting tablets during dispensing.
The individual found that some tablets appeared to have a 'red dot,' while others were discolored or had multiple red-colored spots.
The FDA said the recalled drug was 'cross-contaminated,' suggesting that small amounts of another drug had been mixed in during the manufacturing process. This can happen if the same equipment is used.
It is not clear how many people have an allergy to ranitidine, but previous research suggests this is rare.
The FDA said: 'For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events.'
Unique Pharmaceutical Laboratories distributed the drug in the US via Rising Pharma Holdings, which is also now seeking the return of the medication.
Anyone with a query about the recall has been asked to contact Rising Pharma Holdings.
Warning signs of a reaction to ranitidine include low blood pressure, shortness of breath, difficulty swallowing, throat and facial swelling, itchy skin, a rash and loss of consciousness
In serious cases, patients can develop anaphylaxis, a life-threatening condition where the airways become blocked, leaving someone struggling to breathe.
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