FDA Issues Recall Alert for Cetirizine Allergy Tablets After Red Spots Found on Pills
The FDA announced a recall of four lots of cetirizine hydrochloride tablets after reports of red spots on pills and possible ranitidine contamination. Learn about affected lots, health risks, and what consumers should know.
FDA Announces Recall of Cetirizine Hydrochloride Tablets Due to Contamination Concerns
The U.S. Food and Drug Administration (FDA) has issued a safety alert regarding the voluntary recall of certain lots of Cetirizine Hydrochloride Tablets USP 5 mg after concerns emerged about possible contamination and unusual red markings appearing on the tablets.
The recalled allergy medication was manufactured by Unique Pharmaceutical Laboratories, located in Panoli, Gujarat, India. The company voluntarily withdrew four lots of the product after receiving reports of tablets showing red-colored spots and discoloration.
According to the FDA alert issued on July 18, 2026, the concern involved possible cross-contamination with ranitidine, a medication that has previously been linked to concerns involving the chemical N-Nitrosodimethylamine, commonly known as NDMA.
Cetirizine hydrochloride is a widely used antihistamine medication that helps relieve symptoms associated with seasonal allergies, dust allergies, and hives. It is also commonly recognized by the brand name Zyrtec.
Why Were the Cetirizine Tablets Recalled?
The recall was initiated after a pharmacy technician noticed unusual red dots on the tablets while counting medication for dispensing.
The FDA stated that a product complaint was submitted after tablets were found with visible red markings. Some tablets appeared discolored because of multiple red-colored dots on their surface.
The FDA alert explained that the product complaint involved concerns about the appearance of Cetirizine Hydrochloride Tablets USP 5 mg. The agency also noted that the possible presence of ranitidine contamination created additional safety concerns.
Ranitidine has previously been removed from the market because of concerns that it can break down and form NDMA under certain conditions. NDMA is classified by the FDA as a substance that is likely to cause cancer in humans.
Although the recalled cetirizine tablets were not manufactured as ranitidine products, possible cross-contamination raised concerns about consumer exposure.
Which Cetirizine Products Are Included in the Recall?
The recalled medication was packaged in opaque plastic bottles containing 100 tablets. The product was distributed throughout the United States by Rising Pharma Holdings through wholesalers and retailers.
Consumers should check their medication bottles for the following recalled lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
Anyone who has one of these lot numbers should stop using the medication and follow guidance from their healthcare provider or pharmacist.
Possible Health Risks Linked to the Recall
The FDA warned that people with sensitivity or allergies to ranitidine ingredients may experience serious reactions if they take contaminated cetirizine tablets.
Potential adverse reactions may include severe hypersensitivity reactions and anaphylaxis. Symptoms may involve:
- Low blood pressure
- Difficulty breathing
- Difficulty swallowing
- Swelling of the throat or face
- Severe itching
- Hives
- Loss of consciousness
Anaphylaxis is a serious allergic reaction that can become life-threatening and requires immediate medical attention.
Consumers who experience unusual symptoms after taking the recalled medication should seek medical advice promptly.
Background: Previous Ranitidine and NDMA Concerns
The current recall follows earlier concerns involving ranitidine-containing medications.
In 2020, the FDA announced the removal of original Zantac products after testing identified concerns related to NDMA contamination. Regulators found that ranitidine’s chemical structure could contribute to increasing NDMA levels over time, especially when products were stored for extended periods or exposed to certain conditions.
At the time, FDA officials explained that although many tested samples did not show unacceptable NDMA levels, uncertainty about storage conditions led regulators to recommend removing the products from the market until quality could be guaranteed.
The previous ranitidine concerns continue to influence safety monitoring of medications and manufacturing processes today.
What Should Consumers Do?
Consumers who purchased Cetirizine Hydrochloride Tablets USP 5 mg should check the label on their medication bottle to determine whether it matches one of the recalled lot numbers.
Individuals who have affected products should:
- Stop taking the recalled medication.
- Contact their pharmacist or healthcare provider for replacement options.
- Monitor for any possible allergic reactions or unusual symptoms.
- Report any adverse reactions to the FDA.
The FDA encourages consumers and healthcare professionals to report problems through the MedWatch Adverse Event Reporting Program.
Reports can be submitted online through the FDA MedWatch reporting system.
Consumers may also contact Rising Pharma Holdings at pv@risingpharma.com or qa@risingpharma.com for additional information about the recall.
Why Medication Recalls Matter
Medication recalls are an important part of the healthcare safety system. Regulatory agencies and manufacturers monitor medications after they reach the market to identify unexpected quality issues, manufacturing problems, or potential risks.
While recalls can create concern among patients, they are designed to remove potentially unsafe products and protect public health.
Consumers should avoid ignoring recall notices, especially when a medication is used regularly for chronic conditions, allergies, or other ongoing health concerns.
Final Thoughts
The FDA’s recall of specific Cetirizine Hydrochloride Tablets USP 5 mg lots highlights the importance of medication quality control and safety monitoring. The recall was triggered after reports of red spots appearing on tablets and concerns about possible ranitidine contamination.
Consumers should review their medication bottles, check the listed lot numbers, and contact healthcare professionals if they have questions about continued use.
Staying informed about medication recalls can help patients make safer decisions and reduce potential health risks.
Sources
- U.S. Food and Drug Administration (FDA) recall alert regarding Cetirizine Hydrochloride Tablets USP 5 mg.
- FDA information on ranitidine and NDMA safety concerns.
- FDA MedWatch Adverse Event Reporting Program.
Disclaimer
This article is for informational and educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Consumers should contact a qualified healthcare provider or pharmacist regarding medication concerns, possible side effects, or whether they should continue using a recalled product. Always follow official FDA announcements and guidance from healthcare professionals.