CETIRIZINE HYDROCHLORIDE
Generic: CETIRIZINE HYDROCHLORIDE
Sun Pharmaceutical IndustriesManufacturer
ORALRoute
CETIRIZINE HYDROCHLORIDEActive Substance
2008-06-20Original Approval
CETIRIZINE HYDROCHLORIDE is FDA application ANDA076601, sponsored by TARO. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2025-09-12
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. oTablet/Capsules Imprinted with Wrong ID
Class III2025-09-12
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. oTablet/Capsules Imprinted with Wrong ID
Class III2012-09-20
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., foImpurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclode
Class I2026-06-24
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets a
Top Reported Reactions
1
DRUG INEFFECTIVE
13,541 reports
2
FATIGUE
13,460 reports
3
PAIN
12,547 reports
4
RASH
10,279 reports
5
OFF LABEL USE
9,982 reports
6
ABDOMINAL DISCOMFORT
9,653 reports
7
ALOPECIA
9,545 reports
8
RHEUMATOID ARTHRITIS
9,005 reports
9
SYSTEMIC LUPUS ERYTHEMATOSUS
8,772 reports
10
PEMPHIGUS
8,567 reports