Class I Recall – Cetirizine Hydrochloride Tablets USP 5 mg

Attention: Providers 

Effective date: July 18, 2026

Call to action: Effective July 18, 2026, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) voluntarily recalled four (4) lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross-contamination with Ranitidine.

Product Affected:

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How this impacts providers:This recall may affect providers whose patients were dispensed the impacted lots. Because the recalled cetirizine tablets may be cross-contaminated with ranitidine, affected patients may have been exposed to an unintended medication. Providers should be aware that impacted patients may contact their offices with questions or concerns and may require counseling regarding discontinuation of the recalled product and appropriate replacement therapy.

Next step for Providers:Providers should identify impacted patients, inform them of the recall, advise them regarding appropriate discontinuation and replacement therapy as clinically appropriate, and arrange for return or replacement of the recalled medication.

If you have any questions, please email TCHP Pharmacy at:tchppharmacy@texaschildrens.org.

For access to all provider alerts, log into:www.texaschildrenshealthplan.org/for-providers.