Cetirizine Recall: Check Lots and Get Help for Anaphylaxis Symptoms
The FDA says four lots of cetirizine 5 mg tablets may be contaminated with ranitidine. Check your bottle’s NDC and lot number, and know the emergency signs of a serious allergic reaction—especially if you’ve had reactions to ranitidine.
If you take cetirizine for allergies, it’s worth checking your bottle. The FDA has posted a recall of specific lots of cetirizine hydrochloride 5 mg tablets due to a potential cross-contamination with ranitidine during manufacturing.
For people who are hypersensitive to ranitidine, the FDA describes a reasonable probability that contaminated product could cause serious allergic reactions, including anaphylaxis. The FDA notice also states that no adverse events related to the recall have been reported to date.
What the FDA is recalling
According to the FDA recall notice, the recalled product is:
- Drug: Cetirizine Hydrochloride Tablets USP 5 mg
- Package size: HDPE bottle of 100 tablets
- NDC: 16571-401-10
- Lot numbers: GY825029, GY825030, GY825031, GY825032
- Expiration date: 10/2028
Check your bottle label for both the NDC and the lot number.
Symptoms that could signal anaphylaxis (treat as an emergency)
Anaphylaxis is a medical emergency. The FDA notice highlights severe hypersensitivity concerns in people sensitive to ranitidine, and public health and allergy guidance describes typical anaphylaxis warning signs that can include:
- Trouble breathing (wheezing, shortness of breath)
- Swelling of the throat, face, or other areas
- Hives and widespread itching
- Dizziness or fainting (possible low blood pressure)
- Difficulty swallowing
- Loss of consciousness
If you suspect anaphylaxis, call 911 immediately.
What to do if you have symptoms
- Call 911 right away if symptoms suggest a serious allergic reaction.
- If you have a prescribed epinephrine auto-injector, use it as directed for anaphylaxis—then still seek emergency care.
- Do not wait to see if symptoms improve.
After emergency treatment, contact a clinician promptly—especially if you know you’ve reacted to ranitidine before.
What to do if your bottle matches the recalled lots
- Confirm your bottle’s NDC and lot number match the FDA-listed recalled product.
- Follow the recall steps described in the FDA notice (including any return/disposal or contact instructions).
- Ask your pharmacist or healthcare provider how to proceed with your allergies medication plan.
What’s known—and what isn’t
- Known: The FDA posted a recall of four lots of cetirizine 5 mg tablets due to potential cross-contamination with ranitidine.
- Known: The FDA notice states that no adverse events related to the recall have been reported to date.
- Not fully known: A recall notice describes a potential risk; it does not confirm exactly how much contamination is present in any single bottle.
Bottom line
Check your cetirizine bottle for NDC 16571-401-10 and lot numbers GY825029, GY825030, GY825031, or GY825032 (exp. 10/2028). If you develop symptoms that could be anaphylaxis, get emergency help immediately by calling 911.
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.
