Popular Antihistamine Tablets Recalled Due to Potential Cross-Contamination That May Be Life-Threatening: FDA

Ingrid VasquezThu, July 23, 2026 at 2:22 AM UTC

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Photo example of recalled Cetirizine Hydrochloride tabletsCredit: FDA -

Unique Pharmaceuticals recalled four lots of cetirizine hydrochloride tablets due to potential contamination with ranitidine

Contaminated tablets could cause severe allergic reactions in people sensitive to ranitidine ingredients

Consumers can identify recalled bottles by reviewing the product name, manufacturer details, and lot number on the bottle

A popular antihistamine has been recalled across the United States due to its potential cross-contamination with a heartburn drug that may result in a “life-threatening” reaction.

Unique Pharmaceutical Laboratories (a division of J. B. Chemicals & Pharmaceuticals Ltd.) has voluntarily recalled four lots of 5-milligram cetirizine hydrochloride tablets that were distributed by Rising Pharma Holdings Inc., according to a July 20 notice from the U.S. Food and Drug Administration (FDA).

The FDA said Unique Pharmaceuticals has notified Rising Pharma Holdings Inc. of the recall, which “has notified its distributors and direct customers by email and is arranging for the return of all recalled products.”

Cetirizine, a generic version of Zyrtec, works as an antihistamine medication that prevents and treats allergy symptoms, per the Cleveland Clinic.

Example of label on recalled cetirizine hydrochloride tabletsCredit: FDA

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The FDA explained that the recall occurred due to the tablets’ potential cross-contamination with ranitidine.

Ranitidine works by blocking the release of stomach acid and is used to treat stomach or intestinal ulcers and heartburn from acid reflux, according to the Cleveland Clinic.

“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 including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening,” the FDA stated in its notice.

Unique Pharmaceuticals, however, has not received any reports of “adverse events” related to the recall.

A potential issue with the cetirizine hydrochloride tablets was discovered when a pharmacy technician noticed a red dot on some of them while counting them at the time of dispensing, the FDA said.

Some tablets also appeared discolored due to multiple red dots, according to the FDA.

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The recalled cetirizine hydrochloride tablets were sold in 100-count bottles and distributed nationwide to several wholesalers and retailers.

To identify a recalled bottle, consumers should look at its name, manufacturer details, and lot number.

Example of cetirizine hydrochloride tabletsCredit: FDA

The recalled bottles have a National Drug Code (NDC) number of 16571-401-10 and an expiration date of October 2028.

The impacted lot numbers are: GY825029, GY825030, GY825031, and GY825032.

Consumers with general or medical inquiries regarding the recall can contact Rising Pharma Holdings Inc. from 8:00 a.m. to 5:00 p.m. EST Monday to Friday at 1-844-874-7464.

The distributor can also be contacted via email at pv@risingpharma.com or qa@risingpharma.com.

Adverse reactions to the tablets can also be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.

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Consumers are encouraged to contact their healthcare provider if they have experienced any problems that may be related to the recalled tablets.

PEOPLE has reached out to Rising Pharma Holdings Inc. and J.B. Pharma (J.B. Chemicals & Pharmaceuticals Ltd) for comment.

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