Unique Pharmaceutical Laboratories has recalled four lots of 5-milligram cetirizine hydrochloride tablets nationwide after the allergy medication was found to be potentially cross-contaminated with ranitidine.
The voluntary recall, announced July 18 and published by the Food and Drug Administration (FDA) on July 20, affects 100-count bottles distributed by New Jersey-based Rising Pharma Holdings Inc. to wholesalers and retailers nationwide.
The affected medication was manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd.
The recall involves lot numbers GY825029, GY825030, GY825031 and GY825032, all with an expiration date of October 2028. The product's National Drug Code is 16571-401-10.
The potential contamination was identified after a pharmacy technician reportedly noticed a red dot on some tablets while counting them for dispensing. The FDA said some tablets were also reported to have multiple red dots and appear discolored.
The manufacturer said it has not received any reports of adverse events linked to the recalled medication. However, the FDA warned that people with hypersensitivity to ranitidine ingredients could face serious health complications if they take contaminated tablets.
What Are the Risks of Taking Contaminated Cetirizine?
Cetirizine is an antihistamine commonly used to treat seasonal allergy symptoms and hives. Ranitidine, meanwhile, was historically used to reduce stomach acid and treat conditions such as heartburn.
According to the FDA, people who are hypersensitive to ranitidine could potentially develop severe reactions after taking cetirizine tablets contaminated with the drug.
Possible complications include anaphylaxis, a rapidly developing allergic reaction that can become fatal without immediate treatment. Reactions may manifest as hypotension, dyspnea, and loss of consciousness.
What Does Anaphylaxis Look Like?
Anaphylaxis can affect multiple parts of the body and may worsen within minutes.
Warning signs can include:
- Difficulty breathing or shortness of breath
- Difficulty swallowing
- Throat, tongue, and facial swelling
- Skin reactions such as hives or flushed pale skin
- Dangerously low blood pressure
- Loss of consciousness
Anyone experiencing symptoms of anaphylaxis should seek emergency medical care immediately. People who have been prescribed epinephrine for severe allergies should use it as directed and seek emergency treatment, as symptoms can return or become more severe.
How Can Consumers Identify the Recalled Medication?
Consumers can check the label of their cetirizine bottles for the product name, manufacturer, distributor, and lot number.
The recalled medication has the following identifying information:
- Product: Cetirizine Hydrochloride Tablets USP 5 mg
- Bottle size: 100 tablets
- NDC: 16571-401-10
- Manufacturer: Unique Pharmaceutical Laboratories
- Distributor: Rising Pharma Holdings Inc.
- Lot numbers: GY825029, GY825030, GY825031 and GY825032
- Expiration date: October 2028
The medication was distributed nationwide through wholesalers and retail outlets.
Consumers with questions about the recall can contact Rising Pharma Holdings Inc. at 1-844-874-7464 during business hours. Anyone who believes they experienced a problem after taking the medication should contact a health care professional and can report the event through the FDA's
What Should Consumers Do With Recalled Cetirizine?
People who have one of the affected lots should check with a pharmacist or health care professional about what to do next, rather than continuing to take the recalled medication.
The recall applies specifically to the four identified lots, so consumers should check their bottle's lot number rather than assuming all cetirizine products are affected.
The FDA and the manufacturer have not reported any adverse events related to the recall so far, but consumers with known drug hypersensitivity should remain alert for signs of a serious reaction and seek immediate medical attention if symptoms of anaphylaxis occur.
The recall comes years after ranitidine was removed from the U.S. market over a separate safety concern.
In 2020, the FDA requested the withdrawal of all prescription and over-the-counter ranitidine products after testing found that levels of N-nitrosodimethylamine, or NDMA, could increase over time and under higher temperatures. NDMA is classified as a probable human carcinogen.
