Loratadine recalls

The FDA has published 7 recalls involving Loratadine since 2014. The latest was reported on 3 Nov 2021. Ohm Laboratories 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 recalls7since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Nov 2021

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 3 43%Class III 4 57%

Why loratadine is recalled

Companies

Brands

By year

2021343%
2015229%
2014229%

All loratadine recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
3 Nov 2021Drug	CLASS III	Loratadine-D Extended-Release Tablets (Loratadine recalledLoratadine And Pseudoephedrine Sulfate	Sun Pharmaceutical Industries	Other	Nationwide
3 Nov 2021Drug	CLASS III	AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate recalledKirkland Signature Allerclear D 24 Hr	Sun Pharmaceutical Industries	Other	Nationwide
2 Jun 2021Drug	CLASS II	Children's Loratadine Oral Solution USP, 5 mg recalledChildrens Loratadine	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
21 Oct 2015Drug	CLASS III	Ohm Loratadine Orally Disintegrating Tablets recalledAllergy Relief	Ohm Laboratories	Potency & Assay	Nationwide
24 Jun 2015Drug	CLASS III	Loratadine Orally Disintegrating Tablets USP, 10 mg recalled	Ohm Laboratories	Potency & Assay	Nationwide
30 Apr 2014Drug	CLASS II	Non-Drowsy 24 Hour Formula Allergy Relief recalled by Ohm LaboratoriesLoratadine And Pseudoephedrine Sulfate	Ohm Laboratories	Other	4 states
22 Jan 2014Drug	CLASS II	Loratadine Tablet, 10 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Loratadine?

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.