Cetirizine Recall: Check Your Lot and Know When Allergy Symptoms Are an Emergency

The FDA has posted a voluntary nationwide recall for four lots of cetirizine hydrochloride tablets USP 5 mg (generic Zyrtec) because the product may have been cross-contaminated with ranitidine. The company announcement was posted July 18, 2026, and the FDA publish date is July 20, 2026. The practical next step: check your bottle’s lot number today.

This is especially important for people with hypersensitivity to ranitidine. The FDA’s risk statement explains there is a reasonable probability that ingestion of contaminated tablets could lead to severe hypersensitivity reactions and anaphylaxis in that group.

What’s being recalled (the product and lots)

Product: Cetirizine hydrochloride tablets USP 5 mg
Package: HDPE bottle of 100 tablets
NDC: 16571-401-10
Recalled lot numbers: GY825029, GY825030, GY825031, GY825032
Expiration date listed for these lots: 10/2028

Where to look: The FDA notes the product can be identified by reviewing the product name, manufacturer details, and the lot number displayed on the bottle.

Step-by-step: how to check your cetirizine lot

Find the NDC number on your label: 16571-401-10.
Locate the lot number on the bottle label (often near “LOT” or “Lot”).
Compare your lot to the FDA list: GY825029, GY825030, GY825031, or GY825032.
Check the expiration date. These recalled lots list an expiration date of 10/2028.

If the NDC, lot number, and expiration date all match the recalled information, your bottle is part of the recall.

If your lot is recalled: what to do next

Contact your pharmacist or prescribing clinician for guidance on a safe alternative.
Follow the recall instructions provided in the FDA notice.
If you already took the recalled tablets and you’re feeling unwell, contact a clinician for advice.
If you develop possible anaphylaxis symptoms, seek emergency care immediately (see below).

For general questions about the recall, the FDA notice lists contact information for the distributor, Rising Pharma Holdings Inc.: 1-844-874-7464 (8:00 a.m. to 5:00 p.m. EST, Monday–Friday) or pv@risingpharma.com / qa@risingpharma.com.

Who should take extra care with this specific recall?

The FDA’s risk statement focuses on people with hypersensitivity to ranitidine. If you’ve been told you’re allergic to ranitidine or you’ve had a serious reaction after taking it, take extra care to:

Confirm whether your cetirizine bottle is from one of the recalled lots.
Be alert for signs of a severe allergic reaction after taking a recalled dose.

Emergency warning signs: call 911

Anaphylaxis is a medical emergency. Get emergency help right away if you develop symptoms that may include:

Difficulty swallowing, speaking, or breathing
Swelling in and around the mouth or swelling of the tongue
Wheezing or shortness of breath
Drooling and a sensation of the throat closing (or trouble breathing)
Dizziness, fainting, or loss of consciousness
Generalized hives, itching, or swelling affecting more than one body area
Feeling of impending doom

What to do immediately if anaphylaxis is suspected:

Use epinephrine right away if it has been prescribed to you.
Call 911 (EMS) and get to an emergency department for evaluation and monitoring.
Do not use cetirizine in place of epinephrine. Antihistamines may be helpful for some allergy symptoms, but they are not a substitute for emergency epinephrine in anaphylaxis.

After the emergency is past (or if you feel fine): follow-up and prevention

If you don’t have emergency symptoms but you’re concerned, a practical plan is:

Put recalled bottles aside to avoid accidental reuse.
Ask your pharmacist what alternative product is appropriate for you.
Keep a current medication list and, if you talk with a clinician, consider sharing the lot number and NDC.
If you’ve had severe allergic reactions in the past, consider reviewing your anaphylaxis preparedness plan with your allergist/clinician.

Bottom line: Check your cetirizine bottle’s lot number. Take extra care if you have ranitidine hypersensitivity, and know the warning signs that mean you should call 911 and use prescribed epinephrine.

Key sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.