The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of four batches of 5 mg cetirizine hydrochloride, a generic antihistamine similar to Zyrtec, following the discovery of possible cross-contamination with ranitidine. Ranitidine, a heartburn medication, could trigger life-threatening allergic reactions in sensitive individuals.
The recall was initiated on July 18 by Unique Pharmaceutical Laboratories, a division of J. B. Chemicals & Pharmaceuticals Ltd., located in Panoli, Gujarat, India. This affects a product distributed to wholesalers and retailers across the United States between April and June of this year.
According to the FDA's official notice, laboratory tests found trace amounts of ranitidine—less than 0.5%—in two of the four batches, prompting a precautionary recall of all batches involved.
The risk is particularly critical for those with known hypersensitivity to ranitidine ingredients: consuming a contaminated tablet could result in severe adverse events, including severe hypersensitivity reactions, hypotension, shortness of breath, difficulty swallowing, throat and facial swelling, widespread itching, hives, and loss of consciousness—collectively known as anaphylaxis, a full-body allergic reaction that can be fatal within minutes.
The FDA outlines potential symptoms as "hypotension, shortness of breath, difficulty swallowing, throat and facial swelling, widespread itching, hives, and loss of consciousness, all of which are potentially life-threatening."
Ranitidine, sold under the brand name Zantac, was pulled from the U.S. market in April 2020 after the FDA confirmed it contained NDMA (N-nitrosodimethylamine) at levels considered a probable human carcinogen, with amounts increasing over time in storage.
Details on the Affected Product
The recalled medication is packaged in bottles of 100 tablets made of high-density polyethylene, with NDC code 16571-401-10 and an expiration date of October 2028.
The specific batches being recalled are:
- GY825029
- GY825030
- GY825031
- GY825032
Rising Pharma Holdings Inc. is the distributor responsible for the nationwide sale of the product.
As of the announcement date, the manufacturing company reported no adverse event reports linked to this recall.
Per the FDA, a complaint was filed about the product when a pharmacy technician noticed the issue while counting tablets for dispensing. A red spot appeared on the cetirizine hydrochloride USP 5 mg tablets, and some tablets exhibited discoloration (appearing faded due to multiple red spots).
This recall adds to previous ones in 2026, such as the withdrawal of an alprazolam batch in April due to dissolution issues, and the recall of millions of bottles of eye drops that same month over sterility concerns.
Guidance for Consumers
Consumers possessing 5 mg cetirizine bottles with any of the mentioned batch numbers should cease usage immediately and contact Rising Pharma Holdings Inc. at 1-844-874-7464, available Monday through Friday from 8:00 am to 5:00 pm (Eastern Time), or email pv@risingpharma.com or qa@risingpharma.com.
Adverse reactions can also be reported to the FDA's MedWatch program by calling 1-800-332-1088 or online at the FDA's MedWatch website.
FAQ on Cetirizine Recall Due to Ranitidine Contamination
Why was cetirizine recalled?
The recall was due to potential cross-contamination with ranitidine, which could cause serious allergic reactions in sensitive individuals.
What should I do if I have the recalled cetirizine?
Stop using the product immediately and contact Rising Pharma Holdings Inc. for further instructions.
How can I report adverse reactions?
Adverse reactions can be reported to the FDA's MedWatch program by calling 1-800-332-1088 or online at the FDA's MedWatch website.