Voluntary nationwide recall of Cetirizine 5 mg tablets announced by FDA over potential ranitidine cross-contamination and anaphylaxis risks.
- The FDA announced a voluntary recall of four lots of cetirizine hydrochloride tablets over ranitidine contamination
- The affected lots—GY825029, GY825030, GY825031, and GY825032—have an expiration date of 10/2028
- Exposure can trigger severe hypersensitivity reactions and life-threatening anaphylaxis in sensitive users
Is your self-medicated allergy medicine over-the-counter safe? Taking just one tablet of an over-the-counter antihistamine can start relieving allergy symptoms within 10 minutes, but contamination risks can turn this routine habit into a medical emergency. Millions of people routinely take these medications, unaware of manufacturing defects (1✔ ✔Trusted Source
Unique Pharmaceutical Laboratories Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets
)(2✔ ✔Trusted Source
Cetirizine
).
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The Cetirizine Hydrochloride Recall Details
The U.S. Food and Drug Administration (FDA) announced a voluntary nationwide recall of four lots of cetirizine hydrochloride tablets. The products were manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., and distributed by Rising Pharma Holdings, Inc.. The recall is due to potential cross-contamination with ranitidine, an acid-reducing drug (1✔ ✔Trusted Source
Unique Pharmaceutical Laboratories Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets
)(2✔ ✔Trusted Source
Cetirizine
).
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The Dangers of Ranitidine Cross-Contamination
Exposure to the contaminated allergy tablets poses severe health risks for individuals sensitive to the acid reducer. Contamination can trigger life-threatening hypersensitivity reactions and acute anaphylaxis, which require immediate emergency treatment. Severe symptoms include low blood pressure (hypotension), difficulty breathing (dyspnea), and throat or facial swelling (edema) (3✔ ✔Trusted Source
Ranitidine products recalled because of a nitrosamine impurity
).
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Affected Products: How to Identify the Recalled Lot Numbers
The recall affects 100-count bottles under the National Drug Code (NDC) 16571-401-10, with expiration dates of 10/2028. The affected lot numbers to check are GY825029, GY825030, GY825031, and GY825032. Consumers should inspect their tablets, as some contaminated bottles may contain discolored pills or red spots (1✔ ✔Trusted Source
Unique Pharmaceutical Laboratories Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets
)(3✔ ✔Trusted Source
Ranitidine products recalled because of a nitrosamine impurity
).
What Consumers Should Do and Recommended Replacements
If your bottle matches these lots, stop using the medication immediately and contact the distributor for return instructions. Patients needing allergy relief should consult a pharmacist for replacement antihistamines like fexofenadine or loratadine. Reporting any adverse events to the FDA MedWatch program helps maintain safety standards and prevents future contamination incidents (2✔ ✔Trusted Source
Cetirizine
).
Frequently Asked Questions
Q: Why are the cetirizine hydrochloride tablets being recalled?
A: They are being recalled due to potential cross-contamination with ranitidine, which may trigger severe allergic reactions in sensitive individuals.
Q: What are the symptoms of ranitidine hypersensitivity?
A: Symptoms include low blood pressure (hypotension), difficulty breathing (dyspnea), severe itching, hives, and throat or facial swelling (edema).
Q: How do I know if my cetirizine bottle is included in the recall?
A: Check the NDC number 16571-401-10 and look for lot numbers GY825029, GY825030, GY825031, or GY825032 on the packaging.
Q: What should I do if I have the recalled tablets?
A: Stop taking the medication immediately and contact Rising Pharma Holdings at 1-844-874-7464 or email [email protected] for return details.
Q: Are there safe replacement options for allergy relief?
A: Yes, patients can switch to alternative over-the-counter antihistamines like fexofenadine (Allegra) or loratadine (Claritin) after consulting a doctor.
References:
- Unique Pharmaceutical Laboratories Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets – (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unique-pharmaceutical-laboratories-div-j-b-chemicals-pharmaceuticals-ltd-issues-voluntary-nationwide)
- Cetirizine – (https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/cetirizine )
- Ranitidine products recalled because of a nitrosamine impurity – (https://recalls-rappels.canada.ca/en/alert-recall/ranitidine-products-recalled-because-nitrosamine-impurity )
Source-Medindia