The U.S. Food and Drug Administration (FDA) has announced a nationwide drug recall alert
on the Cetirizine Hydrochloride Tablets by Unique Pharmaceutical Laboratories (a division of J.B. Chemicals & Pharmaceuticals Ltd.) due to possible cross-contamination with ranitidine.
Unique Pharmaceutical cetirizine pill recall was initiated voluntarily and affects four lots of its 5 mg antihistamine tablets. Distributed nationwide by Rising Pharma Holdings Inc., the product is widely used to treat seasonal allergy symptoms such as sneezing, runny nose, and itchy eyes.
Though no adverse events have been reported to date, the ranitidine contamination poses a risk of severe hypersensitivity reactions and life-threatening anaphylaxis for sensitive individuals.
How Did The FDA Cetirizine Tablet Recall Happen?
The investigation began after a pharmacy technician noticed red dots and discoloration on Cetirizine hydrochloride pills while counting them prior to dispensing. This physical change prompted immediate testing by Unique Pharmaceutical, revealing potential ranitidine contamination in cetirizine batches. After these test results, lead a voluntary recall of the Allergy medication across the USA.
Which Products Are Affected in the FDA Cetirizine Tablet Recall?
This nationwide Unique Pharmaceutical cetirizine pill recall affects specific 100-tablet High-Density Polyethylene (HDPE) containers. Consumers and healthcare providers should check their medication packaging details below to identify impacted inventory:
Cetirizine hydrochloride FDA recall details:
- Manufacturer: Unique Pharmaceutical Laboratories (Div. J.B. Chemicals & Pharmaceuticals Ltd.)
- Distributor: Rising Pharma Holdings Inc.
- Recalled Product: Cetirizine Hydrochloride Tablets USP, 5 mg
- National Drug Code No.: 16571-401-10
- Expiration date: October 2028
- Lot numbers: GY825029, GY825030, GY825031, GY825032
All four lot numbers of recalled allergy medications were shipped to major wholesalers, distributors, and retail pharmacies across the United States.
What Are The Health Risks of Ranitidine Contamination in Cetirizine?
Ranitidine is a histamine-2 (H2) receptor blocker designed to reduce stomach acid production. While harmless to most people in standard doses, accidental exposure created by ranitidine contamination in cetirizine poses major health risks to individuals with hypersensitivity to ranitidine or its inactive ingredients.
Ranitidine original formulations were removed from the U.S. market in 2020 due to N-Nitrosodimethylamine (NDMA) impurities before reformulated versions received regulatory approval in 2025.
“For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events,” the FDA warned.
Ingesting cross-contaminated tablets can trigger anaphylaxis—a rapid, severe allergic reaction that requires immediate medical intervention.
Symptoms of Anaphylaxis:
- Cardiovascular: Severe hypotension (sudden drop in blood pressure)
- Respiratory: Dyspnea (shortness of breath) and swelling of the throat or face
- Dermatological: Angioedema (swelling under the skin), intense pruritus (itching), and urticaria (hives)
- Neurological: Dizziness, confusion, or sudden loss of consciousness
What Should Consumers Do?
If you hold tablets from the lot of Unique Pharmaceutical cetirizine pill recall, follow these steps immediately:
- Inspect Your Packaging: Check the NDC code (16571-401-10) and lot numbers on the side of the 100-tablet HDPE bottle.
- Stop Usage: Do not consume tablets from affected lots. Discontinue use even if no discoloration or red spots are visible.
- Contact the Distributor: Call Rising Pharma Holdings Inc. at 1-844-874-7464 (Monday–Friday, 8 a.m.–5 p.m. ET) or email pv@risingpharma.com / qa@risingpharma.com for return and refund procedures.
- Seek Immediate Medical Care: If you experience symptoms of an allergic reaction or anaphylaxis, contact emergency medical services right away.
- Report Incidents: Submit adverse reactions to the FDA MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch or via phone at 1-800-332-1088.
The Outlook: Unique Pharmaceutical Cetirizine Pill Recall
While no illnesses or adverse events have been reported in connection with this Unique Pharmaceutical cetirizine pill recall, the incident underscores the vital necessity of stringent quality control and supply-chain oversight in drug manufacturing.
Similar quality assurance issues have triggered regulatory actions across the pharmaceutical industry, such as the Lupin Pharma eye drop recall over sterility concerns and the Xanax medication recall regarding foreign substance contamination.
Healthcare professionals and pharmacists are advised to quarantine affected stock immediately and assist patients in identifying safe over-the-counter alternatives for allergy relief.
