Cetirizine recalls

The FDA has published 15 recalls involving Cetirizine since 2012. The latest was reported on 29 Jul 2026. Most were for sterility. Torrent Pharma 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 recalls15since 2012

Last 12 months3reported

Class I17% of total

Ongoing4latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 2Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 1 7%Class II 9 60%Class III 5 33%

Why cetirizine is recalled

Companies

Brands

By year

202617%
2025320%
2021213%
2019640%
201817%
201517%
201217%

Ongoing cetirizine recalls

4 active

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS I	Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
29 Oct 2025Drug	CLASS III	Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
29 Oct 2025Drug	CLASS III	Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
16 Apr 2025Drug	CLASS II	Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide

All cetirizine recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS I	Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
29 Oct 2025Drug	CLASS III	Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
29 Oct 2025Drug	CLASS III	Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride	JB Chemicals and Pharmaceuticals	Other	Nationwide
16 Apr 2025Drug	CLASS II	Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
17 Nov 2021Drug	CLASS III	Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine	A-S Medication Solutions	Other	4 states
2 Jun 2021Drug	CLASS II	Cetirizine Hydrochloride Tablets, 10 mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
26 Jun 2019Drug	CLASS II	Cetirizine Oral Solution 1 mg/mL, Children's Allergy recalled	P & L Developments	Sterility	Nationwide
26 Jun 2019Drug	CLASS II	Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy recalled	P & L Developments	Sterility	Nationwide
26 Jun 2019Drug	CLASS II	Cetirizine Oral Solution 1 mg/mL, Up & Up recalled by P & L Developments	P & L Developments	Sterility	Nationwide
19 Jun 2019Drug	CLASS II	Cetirizine HCL Oral Solution, USP 1mg/mL - BULK, PLD recalled	Torrent Pharma	Sterility	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.