US allergy drug cetirizine recalled: FDA warns of serious reactions linked to possible ranitidine contamination

A nationwide recall of four batches of cetirizine hydrochloride 5 mg tablets, a generic antihistamine commonly used to treat seasonal allergies, has been issued after potential cross-contamination with the heartburn drug ranitidine was identified, according to the US Food and Drug Administration (FDA).

FDA Recalls Allergy Tablets Due to Possible Ranitidine Contamination

Unique Pharmaceutical Laboratories, a division of JB Chemicals & Pharmaceuticals Ltd., announced a voluntary recall on July 18. The FDA issued a recall notice on July 20, stating that Rising Pharma Holdings Inc. distributed the affected tablets across the US. The drugs were sold in 100-tablet bottles made of high-density polyethylene under the name Rising Pharma Holdings.

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The recall was initiated after a pharmacy technician noticed a red dot on some tablets while counting and filling them for dispensing. Other tablets were found to be discolored, leading to a product recall and other concerns about a possible quality issue.

The FDA said the affected drug is cetirizine hydrochloride USP 5 mg tablets, a generic version of the active ingredient used in allergy medications such as Zyrtec. The agency said the tablets may have been cross-contaminated with ranitidine.

Why is this cross-contamination so worrisome?

The potential contamination concerns especially consumers who are hypersensitive to the components contained in ranitidine. According to the FDA, exposure can lead to serious adverse effects, including severe hypersensitivity reactions and anaphylaxis.

Possible symptoms listed by the agency include hypotension, shortness of breath, difficulty swallowing, swelling of the throat and face, generalized itching, hives and loss of consciousness.

The FDA said such reactions can be life-threatening. However, no adverse events associated with the recall have been reported to Unique Pharmaceutical Laboratories at the time of notification.

Affected products can be identified by the product name, manufacturer information and batch number printed on the bottle. All four recalled batches have an expiration date of October 2028 and carry the same National Drug Code (NDC), 16571-401-10.

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The recalled batch numbers are:

The tablets were manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc. to wholesalers and retailers nationwide. Rising Pharma has notified its customers and is arranging for all recalled products to be returned.

The FDA’s recall notice said the problem was identified through a complaint regarding the appearance of red dots on cetirizine tablets. The company said some tablets appeared colored due to the many red colored dots.

Consumers with the affected product were advised to check the batch number on the bottle and avoid using tablets from the recalled batches until they receive instructions from a healthcare professional or until the product is returned through the recall process.

The recall is made with the knowledge of the FDA. The agency also said that adverse reactions or quality problems associated with the product can be reported through the MedWatch program.

What is Rantidine?

Ranitidine, historically used to treat heartburn and other acid-related conditions, has previously been subject to significant regulatory scrutiny in the US.

The FDA has previously expressed concern about the possible presence of the impurity N-nitrosodimethylamine, or NDMA, in ranitidine products, although the current recall of cetirizine specifically addresses the possibility of cross-contamination with ranitidine and the risk of hypersensitivity reactions.