FDA Recall: Check Cetirizine Bottle for Ranitidine Cross-Contamination

The FDA says you should check your cetirizine (a common allergy medicine) bottle after Unique Pharmaceutical Laboratories issued a voluntary recall of specific lots of cetirizine hydrochloride 5 mg tablets due to potential cross-contamination with ranitidine during manufacturing.

If your bottle matches one of the four affected lots listed by FDA, do not use those tablets. Ask a pharmacist or clinician about a safe replacement.

What was recalled (and why)

According to the FDA, the recall involves cetirizine hydrochloride tablets USP 5 mg in HDPE bottles of 100 with NDC 16571-401-10. The affected lot numbers are:

GY825029 (expiration 10/2028)
GY825030 (expiration 10/2028)
GY825031 (expiration 10/2028)
GY825032 (expiration 10/2028)

FDA’s concern is potential cross-contamination with ranitidine. Risk is expected to be highest for people with known ranitidine allergy if exposure occurs.

Who should pay attention

Anyone with one of the affected lots: check the lot number and expiration date printed on your cetirizine bottle.
People with known ranitidine allergy: be extra alert for symptoms of a severe allergic reaction.

What readers can do now (step-by-step)

Find your bottle’s details (product name, lot number, and expiration date).
Compare the lot number on your bottle to FDA’s list: GY825029, GY825030, GY825031, or GY825032 (each with expiration 10/2028).
If it matches an affected lot: stop using those tablets and ask your pharmacist or clinician for an alternative.
If it does not match: this recall-specific guidance generally does not apply to your bottle.

Emergency warning signs: when to call 911

Severe allergic reactions (anaphylaxis) can worsen quickly. Get emergency medical help right away (call 911) if you (or the person you care for) have symptoms such as:

Trouble breathing (wheezing, shortness of breath) or a feeling of throat tightness
Swelling of the face, lips, tongue, or throat
Hives or widespread rash
Dizziness, fainting, or feeling very weak

What’s confirmed—and what’s not known

Confirmed by FDA: the recall applies to four specified lots of cetirizine 5 mg tablets (NDC 16571-401-10) with expiration 10/2028.
Confirmed by FDA: the issue involves potential cross-contamination with ranitidine during manufacturing.
Not known for an individual bottle: exposure risk can’t be determined without the lot/expiration information—only the label details tell you whether your product is part of the recalled group.

Questions to ask your pharmacist or clinician

“If my lot is on the recall list, what alternative should I use?”
“Given my allergy history, is there a particular medication formulation I should avoid?”
“Should I update my medication/allergy record?”

Bottom line

Check your cetirizine bottle for the lot number. If it matches one of the four affected lots, stop using the tablets and ask a pharmacist or clinician for a replacement. If you develop signs of a severe allergic reaction, seek emergency care immediately.

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.