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Is Loratadine recalled?

34 FDA recalls mention Loratadine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Loratadine.

Class II · Moderate risk Terminated Dec 20, 2023

Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured…

Reason CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Lupin Pharmaceuticals Inc. NDC 68180-153-01 D-0221-2024

Class II · Moderate risk Ongoing Jun 23, 2022

CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE…

Reason CGMP Deviations: product held outside appropriate storage temperature conditions.

Family Dollar Stores, Llc. D-1451-2022

Class III · Low risk Terminated Oct 12, 2021

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs…

Reason Failed Moisture Limits

Sun Pharmaceutical Industries INC NDC 63981-724-15 D-0069-2022

Class III · Low risk Terminated Oct 12, 2021

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)…

Reason Failed Moisture Limits

Sun Pharmaceutical Industries INC NDC 0904-5833-15 D-0068-2022

Class II · Moderate risk Terminated Mar 15, 2021

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 51672-2131-8 D-0572-2021

Class II · Moderate risk Terminated Mar 15, 2021

LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0547-2021

Class III · Low risk Terminated Jul 28, 2015

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929…

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

Ohm Laboratories, Inc. NDC 41250-527-31 D-0039-2016

Class III · Low risk Terminated Jul 28, 2015

Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM…

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

Ohm Laboratories, Inc. NDC 0363-0527-69 D-0038-2016

Class III · Low risk Terminated Jul 28, 2015

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0…

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

Ohm Laboratories, Inc. NDC 49348-930-01 D-0037-2016

Class III · Low risk Terminated Jul 28, 2015

Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis…

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

Ohm Laboratories, Inc. NDC 11673-527-31 D-0036-2016

Class III · Low risk Terminated Jul 28, 2015

Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC…

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

Ohm Laboratories, Inc. NDC 21130-527-69 D-0034-2016

Class III · Low risk Terminated Jul 28, 2015

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug…

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

Ohm Laboratories, Inc. NDC 68016-527-31 D-0033-2016

Class III · Low risk Terminated Jul 28, 2015

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston…

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

Ohm Laboratories, Inc. NDC 51660-527-31 D-0032-2016

Class III · Low risk Terminated Jul 28, 2015

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778…

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

Ohm Laboratories, Inc. NDC 0904-5806-15 D-0031-2016

Class III · Low risk Terminated Jul 28, 2015

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH…

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

Ohm Laboratories, Inc. NDC 37205-745-65 D-0030-2016

Class III · Low risk Terminated Jul 28, 2015

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio…

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

Ohm Laboratories, Inc. D-0029-2016

Class III · Low risk Terminated Jul 28, 2015

Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson…

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

Ohm Laboratories, Inc. NDC 62011-0073-1 D-0028-2016

Class III · Low risk Terminated Jul 28, 2015

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box…

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

Ohm Laboratories, Inc. NDC 24385-0161-52 D-0027-2016

Class III · Low risk Terminated Jul 28, 2015

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New…

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

Ohm Laboratories, Inc. D-0026-2016

Class III · Low risk Terminated Jul 28, 2015

Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets…

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

Ohm Laboratories, Inc. NDC 41163-528-69 D-0025-2016

Class III · Low risk Terminated Jul 28, 2015

Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count…

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

Ohm Laboratories, Inc. D-0024-2016

Class III · Low risk Terminated Jul 28, 2015

CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count…

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

Ohm Laboratories, Inc. D-0023-2016

Class III · Low risk Terminated Jul 28, 2015

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)…

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

Ohm Laboratories, Inc. NDC 41520-525-69 D-0022-2016

Class III · Low risk Terminated Jul 28, 2015

Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed…

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

Ohm Laboratories, Inc. D-0021-2016

Class III · Low risk Terminated Jul 28, 2015

Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC…

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

Ohm Laboratories, Inc. D-0020-2016