Loratadine — Class III drug recall D-022-2014
Terminated recall by Novartis Consumer Health, reported 2013-12-04, distributed nationwide. Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
| Recall number | D-022-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-09-03 |
| Classified | 2013-11-27 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 11,846,608 blister |
| UPC / GTIN / UDI-DI | 00032251004292, 00050428046784, 00050428046791, 00050428065747, 00050428065822, 00050428068595, 00050428160282, 00050428579350, 00300670668150, 00300670674106, 00300670674304, 00300670675004, 00300670675103, 00300670675127, 00300670675301, 00300670675400, 00300676122304, 00300676255736, 00400910131502, 00681131739276, 00681131739283 |
| Lot numbers | 1/14, 10/13, 10098127, 10098129, 10099649, 10099650, 10101299, 10101302, 10101303, 10103516, 10103517, 10106236, 10106237, 10106238, 10107030, 10109434, 10109436, 10109438, 10109861, 10109863, 10111296, 10112222, 10112223, 10114571, 10114573, 10116503, 10116506, 10118377, 10122379, 11/13, 12/13, 2/14, 3/14, 4/14, 5/14, 6/14, 7/14, 8/14, 9/13 |
Product
Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN. 2) FAMILY DOLLAR LABEL: Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC. 3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC. 4) TARGET LABEL: Allergy Relief Medication, loratadine, 10 mg/antihistamine, packaged in 10 tablet (UPC 300670675103), 15 tablet (UPC 300670668150), 30 tablet (UPC 300670675301), 40 tablet (UPC 300670675400), and 60 tablet (UPC 300670675004) blister packs. It is also packaged in 120 tablet (UPC 300670675127) and 180 tablet (UPC 300676255736) bottles. Dist. by Target Corporation, Minneapolis, MN. 5) PRIVATE LABEL: Loratadine 10mg, Antihistamine, packaged in 10 tablet (UPC 300670674106) and 30 tablet (UPC 300670674304) blister packs. Manufactured and Distributed by: Novartis Consumer Health, Inc., Lincoln, NE. 6) WALMART LABEL, Equate, Allergy Relief, Loratadine Tablets, 10 mg, Antihistamine, packaged in 10 tablet (UPC 681131739276) and 30 tablet (UPC 681131739283) blister packs. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. 7) CVS LABEL: CVS Pharmacy, Allergy Relief, Loratadine 10mg/Antihistamine, packaged in 5 tablet (UPC 050428068595), 10 tablet (UPC 050428046784), 20 tablet (UPC 050428065747) (UPC 050428579350), and 30 tablet (UPC 050428046791) blister packs. Also packaged in 120 tablet (UPC 050428065822) and 365 tablet (UPC 050428160282) plastic bottles. Manufactured by: Novartis Consumer Health, Inc., Lincoln, NE, for: CVS Pharmacy, Inc., Woonsocket, RI.
Reason for recall
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-022-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.