Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg
Recalled by Unique Pharmaceutical Laboratories (Rising Pharma Holdings)
Drug recall
Unique Pharmaceutical Laboratories (Rising Pharma Holdings)
Classification pending
The agency has not yet assigned a severity class to this recall. Classification usually follows the initial announcement by several weeks — check the official notice for the latest status.
Unique Pharmaceutical Laboratories (Rising Pharma Holdings) has recalled Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg, according to the U.S. Food and Drug Administration (FDA). The recall was announced on July 20, 2026. The FDA has not yet assigned it a severity classification — that usually follows the initial announcement by several weeks.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg. The company behind the recall is Unique Pharmaceutical Laboratories (Rising Pharma Holdings). The FDA describes the product as: “Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg”
Why was Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg recalled?
According to the FDA, the stated reason for the recall is: “Potential cross contamination with ranitidine. Cetirizine is a common allergy medicine, and ranitidine was withdrawn from the U.S. market in 2020 over concerns about a nitrosamine impurity, so its unintended presence is treated seriously.” In plain terms, this recall relates to a chemical impurity.
This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.
What should you do?
If you think you may have bought Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg, compare it against the product description and identifying codes (Cetirizine Hydrochloride Tablets USP 5 mg from Rising Pharma Holdings. Check the lot number on your bottle against the official notice and ask your pharmacist…) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Unique Pharmaceutical Laboratories (Rising Pharma Holdings) or your local health authority.
About this recall
This recall was distributed in Nationwide. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Nationwide.
What chemical impurity actually means
This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.
In this case, the concern applies specifically to Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg from Unique Pharmaceutical Laboratories (Rising Pharma Holdings) — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Cetirizine Hydrochloride Tablets USP 5 mg from Rising Pharma Holdings. Check the lot number on your bottle against the official notice and ask your pharmacist about a replacement before stopping an allergy medicine you rely on.
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- July 20, 2026
- Distributed in
- Nationwide
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg recalled?+
According to the FDA: Potential cross contamination with ranitidine.
How serious is this recall?+
Classification pending. The agency has not yet assigned a severity class to this recall. Classification usually follows the initial announcement by several weeks — check the official notice for the latest status.
What should I do if I have Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: FDA-PR-CETIRIZINE-2026. Information last synced from the FDA on July 31, 2026.