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Browse Drug Recalls

23 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 23 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 23 FDA drug recalls.

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DateProductReasonClassFirm
Jul 28, 2015 Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Equaline Original Prescription Strength, loratadine orally disintegrating tab... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packag... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATIN... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-cou... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Dis... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablet... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a)... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets pe... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Oral... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, D... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged i... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) ... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Jul 28, 2015 Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
May 4, 2015 Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy R... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Feb 7, 2014 Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephed... Defective Container: An unacceptable level of blister defects have been identified in Loratadine ... Class II Ohm Laboratories, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.