Is Loratadine recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Loratadine (32 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Loratadine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Loratadine recalls on record

none so far in 2026; 32 on record, newest first

May 4, 2015 Class III · Low risk

Loratadine Orally Disintegrating Tablets USP

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Terminated Wrong potency / content Ohm Laboratories, Inc. D-1142-2015

Dec 30, 2014 Class II · Moderate risk

Children's Loratadine Syrup

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

Terminated Particulate / foreign matter Taro Pharmaceuticals U.S.A., Inc. D-0383-2015

Nov 14, 2014 Class II · Moderate risk

Loratadine active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-769-2015

Feb 7, 2014 Class II · Moderate risk

Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

Terminated Packaging defect Ohm Laboratories, Inc. NDC 30142-0724-69 D-1256-2014

Sep 11, 2013 Class III · Low risk

Loratadine 24 HR-OTC

Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-5268-00 D-0239-2015

Sep 3, 2013 Class III · Low risk

Loratadine

Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

Terminated Failed specification Novartis Consumer Health D-022-2014

Jul 2, 2013 Class II · Moderate risk

LORATADINE Tablet

Labeling: Label Mixup; LORATADINE Tablet, 10 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: W002650, EXP: 6/5/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 05445800022, Pedigree: AD21858_4, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003217, EXP: 6/14/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-570-2014