Cetirizine recalls
The FDA has published 18 recalls involving Cetirizine since 2012. The latest was reported on 29 Jul 2026. Most were for sterility. P & L Developments has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 18 since 2012
Last 12 months 3 reported
Class I 1 6% of total
Ongoing 4 latest 29 Jul 2026
Recalls per month, last 24 months click a bar for that month Severity split
1 6%10 56%7 39%
Why cetirizine is recalled
Ongoing cetirizine recalls 4 active
All cetirizine recalls, newest first 18 total Reported Class Recall Company Reason Where 29 Jul 2026 Drug CLASS I Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals and Cetirizine Hydrochloride JB Chemicals and Pharmaceuticals Other Nationwide 29 Oct 2025 Drug CLASS III Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals and Cetirizine Hydrochloride JB Chemicals and Pharmaceuticals Other Nationwide 29 Oct 2025 Drug CLASS III Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals and Cetirizine Hydrochloride JB Chemicals and Pharmaceuticals Other Nationwide 16 Apr 2025 Drug CLASS II Cetirizine Hydrochloride Tablets, USP, 10mg packs recalled Cetirizine Hcl Glenmark Pharmaceuticals Inc., USA Manufacturing (CGMP) Deviations Nationwide 17 Nov 2021 Drug CLASS III Cetirizine hydrochloride recalled by A-S Medication Solutions Cetirizine A-S Medication Solutions Other 4 states 2 Jun 2021 Drug CLASS II Cetirizine Hydrochloride Tablets, 10 mg recalled by Cardinal Health Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 26 Jun 2019 Drug CLASS II Cetirizine Oral Solution 1 mg/mL, Children's Allergy recalled P & L Developments Sterility Nationwide 26 Jun 2019 Drug CLASS II Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy recalled P & L Developments Sterility Nationwide 26 Jun 2019 Drug CLASS II Cetirizine Oral Solution 1 mg/mL, Up & Up recalled by P & L Developments P & L Developments Sterility Nationwide 19 Jun 2019 Drug CLASS II Cetirizine HCL Oral Solution, USP 1mg/mL - BULK, PLD recalled Torrent Pharma Sterility Nationwide 19 Jun 2019 Drug CLASS II Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only recalled Torrent Pharma Sterility Nationwide 19 Jun 2019 Drug CLASS II Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL recalled Torrent Pharma Sterility Nationwide 21 Nov 2018 Drug CLASS II children's allergy (cetirizine hydrochloride) Oral Solution recalled Childrens Allergy Taro Pharmaceuticals U Potency & Assay Nationwide 30 Dec 2015 Drug CLASS III Cetirizine HCl, sold over the counter under the following recalled Equaline All Day Allergy Perrigo Potency & Assay Nationwide 10 Jun 2015 Drug CLASS III Cetirizine HCl Chewable Tablet, 10 mg in one blister recalled by Sandoz Sandoz Potency & Assay Nationwide 7 May 2014 Drug CLASS III Cetirizine Hydrochloride Chewable Tablets, 5 mg recalled Caraco Pharmaceutical Laboratories Potency & Assay Nationwide 29 Jan 2014 Drug CLASS II Cetirizine HCL, Tablet, 5 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 24 Oct 2012 Drug CLASS III Children's Cetirizine HCl Chewable Tablets 5 mg recalled Cetirizine Hydrochloride Sandoz Potency & Assay Nationwide
Should you stop taking Cetirizine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.