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Allergy medication recalled over potentially ‘life-threatening’ cross-contamination
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by Addy Bink - 07/21/26 10:16 AM ET
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by Addy Bink - 07/21/26 10:16 AM ET
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How recalls are decided
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(NEXSTAR) – Several lots of an over-the-counter medication used for allergies have been recalled after they were potentially contaminated with a different medication that could cause life-threatening reactions among some consumers.
According to a notice shared by the U.S. Food and Drug Administration, four lots of cetirizine hydrochloride tablets have been voluntarily recalled by Unique Pharmaceutical Laboratories over the cross-contamination.
Cetirizine hydrochloride is used to treat common allergy symptoms, like sneezing, runny nose, itchy nose or throat, or irritated eyes, Medline Plus explains.
The tablets were believed to have been cross-contaminated with ranitidine. Because the antihistamine can block the release of stomach fluids, it’s frequently used for those with ulcers or heartburn, according to the Cleveland Clinic.
However, some consumers may be hypersensitive to the ingredients in ranitidine, the recall notice explains. They may experience “serious adverse events, including severe hypersensitivity reactions and anaphylaxis.” This could lead to low blood pressure, difficulty breathing or swallowing, swelling in the throat and face, itchy skin, hives, or even loss of consciousness, “which are all life-threatening.”
Select lots of the cetirizine hydrochloride tablets seen here have been recalled over a cross-contamination risk. (US FDA)
A pharmacy technician reportedly discovered the issue, noting a red dot on the cetirizine hydrochloride tablets and others that were discolored.
There have been no reported adverse incidents reported as a result of the medication, the recall notice says.
The recalled medication was distributed in 100-tablet bottles nationwide by Rising Pharma Holdings Inc. The below table outlines which bottles of the tablets have been recalled:
| Product Description | Lot<br>Numbers | Expiration<br>Date |
|---|---|---|
| Cetirizine Hydrochloride <br>Tablets USP 5 mg, Pack <br>100’s HDPE container | GY825029 | 10/2028 |
| Cetirizine Hydrochloride <br>Tablets USP 5 mg, Pack <br>100’s HDPE container | GY825030 | 10/2028 |
| Cetirizine Hydrochloride <br>Tablets USP 5 mg, Pack <br>100’s HDPE container | GY825031 | 10/2028 |
| Cetirizine Hydrochloride <br>Tablets USP 5 mg, Pack <br>100’s HDPE container | GY825032 | 10/2028 |
The company has already contacted customers who were impacted by email to arrange returns. If you have any questions, you can contact Rising Pharma Holdings at 1-844-874-7464 during business hours, or via email at pv@risingpharma.com or qa@risingpharma.com.
In 2020, the FDA called for ranitidine to be removed from the market amid a safety investigation. Some products were found to have low levels of N-Nitrosodimethylamine, or NDMA, which can cause cancer. Last year, a reformulated ranitidine tablet was approved by the FDA, marking its return.
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