Loratadine, USP 10 mg, Antihistamine
Medicine recall D-022-2014. Published in FDA’s Enforcement Report on Dec 4, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 4, 2013. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 11,846,608 blister packs how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
11,846,608 blister packs, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) DG Health Allergy Relief 60 tablet packages: Lot 10114571, exp 4/14 and Lot 10114573, exp 5/14. 30 tablet packages lot and exp date: 10098129, 9/13; 10099649, 10/13; 10101302, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14;…
Every code shown here, 1,996 characters
1) DG Health Allergy Relief 60 tablet packages: Lot 10114571, exp 4/14 and Lot 10114573, exp 5/14. 30 tablet packages lot and exp date: 10098129, 9/13; 10099649, 10/13; 10101302, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14; 10109436, 2/14; 10111296, 3/14; 10112222, 3/14 and 10114573, 5/14. 2) DG Health Allergy Relief Lot number and exp date: 10122379, 8/14. 3) Family Dollar Allergy Relief Lot number and exp date: 10098127, 9/13; 10098129, 9/13; 10099649, 10/13; 10099650, 10/13; 10101299, 11/13; 10101303, 11/13; 10103517, 12/13; 10106236, 1/14; 10106237, 1/14; 10107030, 2/14; 10109434, 2/14; 10109436, 2/14; 10109438, 2/14; 10109861, 3/14; 10109863, 2/14; 10112223, 3/14; 10116503, 5/14; 10116506, 6/14 and 10118377, 7/14. 4) Target Allergy Relief Lot number and exp date: 10 ct blister pack: 10098127, 9/13; 10103516, 12/13; 10106238, 1/14; 10109863, 2/14; 10111298, 3/14; 10111300, 3/14; 10118377, 7/14; 10122382, 10/14 and 10126772, 11/14. 15 ct blister pack: 10101299, 11/13, 10109434, exp 2/14 and 10103515, 12/13. 30 ct blister pack: 10098127, 9/13; 10099646, 9/13; 10099648, 10/13; 10101298, 11/13; 10101303, 11/13; 10106234, 12/13; 10106235, 12/13; 10106237, 1/14; 10107028, 1/14; 10109437, 2/14; 10109864, 2/14; 10112221, 3/14; 10114570, 4/14; 10114571, 4/14; 10114572, 4/14; 10116505, 5/14; 10118374, 6/14; 10122380, 9/14; 10122382, 10/14 and 10126771, 10/14. 5) PRIVATE LABEL Lot number and exp date: 10 ct blister pack: 10099646, 9/13; 10099649, 10/13; 10099650, 10/13; 10101298, 11/13; 10103516, 12/13; 10103517, 12/13; 10106238, 1/14; 10109434, 2/14; 10109863, 2/14; 10112221, 3/14; 10112223, 3/14; 10118377, 7/14 and 10122381, 9/14. 30 ct blister pack: 10098127, 9/13; 10099646, 9/13; 10099648, 10/13; 10099649, 10/13; 10099650, 10/13; 10101298, 11/13; 10103516, 12/13; 10106235, 12/13; 10107030, 2/14; 10109436, 2/14; 10109864, 2/14; 10111297, 3/14; 10112221, 3/14; 10114569, 4/14; 10114570, 4/14; 10114571, 4/14; 10116503, 5/14; 10116504, 5/14; 10116505, 5/14;…
FDA’s list runs to 3,738 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
UPC
300436122 -
UPC
300676122304 -
UPC
032251004292 -
UPC
400910131502 -
UPC
300670675103 -
UPC
300670668150 -
UPC
300670675301 -
UPC
300670675400 -
UPC
300670675004 -
UPC
300670675127 -
UPC
300676255736 -
UPC
300670674106 -
UPC
300670674304 -
UPC
681131739276 -
UPC
681131739283 -
UPC
050428068595 -
UPC
050428046784 -
UPC
050428065747 -
UPC
050428579350 -
UPC
050428046791 -
UPC
050428065822 -
UPC
050428160282
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 3, 2013.
- FDA classified it on Nov 27, 2013.
- FDA’s Enforcement Report published it on Dec 4, 2013.
- FDA terminated it on Nov 4, 2014.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Novartis Consumer Health, of Lincoln, NE.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,738 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.