FDA Warns of Red Dots on Recalled Allergy Capsules

The FDA said concerns that four lots of Cetirizine Hydrochloride Tablets USP 5 mg are contaminated with ranitidine led Unique Pharmaceutical Laboratories of Panoli, Gujarat, India to voluntarily withdraw the tablets.

Juliette Fairley

Published: 7/22/2026, 3:25:38 PM EDT

FDA Warns of Red Dots on Recalled Allergy Capsules — Cetirizine Hydrochloride Tablets (FDA)

The U.S. Food and Drug Administration (FDA) announced the recall of a popular allergy and hives medicine due to cross-contamination involving red marks on the pills and ranitidine.

Concerns that four lots of Cetirizine Hydrochloride Tablets USP 5 mg are contaminated with ranitidine led Unique Pharmaceutical Laboratories of Panoli, Gujarat, India to voluntarily withdraw the tablets, according to a July 18 FDA alert.

Ranitidine chemically disintegrates into N-Nitrosodimethylamine (NDMA), a chemical classified by the FDA as likely to cause cancer in humans.

“Product complaint received that a pharmacy technician identifies the discrepancy while counting the tablets at the time of dispensing,” the FDA alert said. “A product complaint reported about appearance of red dot on tablets of Cetirizine Hydrochloride Tablets USP 5 mg and some tablets are discolored (Appeared as discolored due to multiple red colored dots on tablets).”

Unique Pharmaceutical Laboratories management did not respond to requests for comment by the time of publication.

Cetirizine, also known under the brand name of Zyrtec, is an antihistamine commonly used to treat seasonal allergies, dust sensitivity, and hives.

The recalled product is packaged in standard opaque plastic pill bottles of 100 and was distributed nationwide by Rising Pharma Holdings to several wholesalers/retailers.

The following four lot numbers are named in the recall: GY825029, GY825030, GY825031 and GY825032.

In 2020, the FDA announced the recall of original Zantac due to NDMA contamination. In that recall, federal officials believed that ranitidine's molecular structure caused toxic NDMA buildup to continually increase inside stored medicines under heat and over the long term.

"We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock said on April 1, 2020. "However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured."

For consumers with a hypersensitivity to the ingredients in ranitidine, it is possible that ingesting cetirizine tablets contaminated with ranitidine could result in serious adverse events, according to the FDA cetirizine recall alert.

Adverse events include severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritus, urticaria, and loss of consciousness.

Consumers experiencing adverse reactions are urged to contact a medical provider, the distributor at [email protected] or [email protected], as well as to report the problem to the FDA's MedWatch Adverse Event Reporting program Online at www.fda.gov/medwatch/report.htm