Cetirizine Hydrochloride is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
Class I recall (most serious) — July 29, 2026: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. Only the lots listed are affected. Check the lots
- Type
- Over the counter (OTC)
- Brand names
- Zyrtec Allergy, Childrens Zyrtec, Childrens Zyrtec Allergy, childrens dye free allergy relief
- Taken
- Oral
- Label
- Kenvue Brands LLC, revised April 27, 2026 · full label on DailyMed
Purpose
Antihistamine
What it is used for
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Active ingredient
Cetirizine HCl 10 mg
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are
taking tranquilizers or sedatives.
When using this product
drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
Warnings
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Pregnancy or breastfeeding
If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.
Keep out of reach of children
. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Cetirizine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class I Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings…
Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Lots, distribution and details
- Product
- Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
- Lots / codes
- Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
- Distribution
- Nationwide in the USA
- Quantity
- 34,020 100-count bottles.
- Recall started
- June 24, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0732-2026
-
Class III Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Hold…
Reason: Tablet/Capsules Imprinted with Wrong ID
Lots, distribution and details
- Product
- Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
- Lots / codes
- Lot # PY925014, PY925013, Exp. 1/31/2028
- Distribution
- U.S. Nationwide
- Quantity
- 13,440 bottles
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0033-2026
-
Class III Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Hold…
Reason: Tablet/Capsules Imprinted with Wrong ID
Lots, distribution and details
- Product
- Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
- Lots / codes
- Lot # PY925014A; Exp. 1/31/2028
- Distribution
- U.S. Nationwide
- Quantity
- 9936 bottles
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0032-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Cetirizine Hydrochloride
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID dc613bd5-70fd-1d9b-e053-2995a90a41cd.