🔍 RecallPedia

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.

Class I - Dangerous
💊 Drugs Recalled: September 3, 2013 Novartis Consumer Health Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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; 10118376, 7/14; 10118377, 7/14; 10118378, 7/14; 10122379, 8/14; 10122382, 10/14 and 10126770, 10/14. 6) WALMART BRAND, Equate, Allergy Relief, Loratadine Lot code and Exp date: 10 ct blister packs 10098127, 9/13; 10099648, 10/2013; 10099649, 10/13; 10101298, 11/13; 10101303, 11/13; 10103516, 12/13; 10106234, 12/13; 10106238, 1/14; 10107028, 1/14; 10109436, 2/14; 10109437, 2/14; 10109863, 2/14; 10109864, 2/14; 10111297, 3/14 and 10111298, 3/14. 30 ct blister pack 10098127, 9/13; 10099647, 9/13; 10099650, 10/13; 10101299, 11/13; 10103513, 11/13; 10103517, 12/13; 10106235, 12/13; 10107029, 1/14; 10107031, 2/14; 10109434, 2/14; 10109437, 2/14; 10109862, 2/14; 10111297, 3/14; 10111299, 3/14; 10111300, 3/14; 10112220, 3/14; 10112221, 3/14; 10114569, 4/14; 10116504, 5/14; 10116506, 6/14; 10118374, 6/14; 10118376, 7/31/2014 and 10118378, 7/14. 7) CVS Pharmacy, Allergy Relief Lot Code and Exp date: 5 ct blister pack 10101298, 11/13; 10106235, 12/13; 10109434, 2/14; 10109864, 2/14; 10112224, 4/14; 10114572, 4/14; 10116504, 5/14 and 10118374, 6/14. 10 ct blister packs: 10099646, 9/13; 10103516, 12/13; 10106238, 1/14; 10109434, 2/14; 10109863, 2/14; 10112221, 3/14 and 10118374, 6/14. 20 ct blister packs: 10099646, 9/13; 10099649, 10/13; 10103516, 12/13; 10106238, 1/14; 10107030, 2/14 and 10111297, 3/14. 10 + 10 ct blister pack: 10106234, 12/13. 30 ct blister packs: 10098127, 9/13; 10099646, 9/13; 10101298, 11/13; 10101302, 11/13; 10103517, 12/13; 10106235, 12/13; 10107028, 1/14; 10107031, 2/14; 10109864, 2/14; 10114573, 5/14 and 10118374, 6/14. 120 ct bottles: 10107028, 1/14 and 10109861, 2/14. 365 ct bottles: 10099647, 9/13; 10101297, 10/13; 10103515, 12/13; 10109860, 2/14; 10114569, 4/14; 10116505, 5/14 and 10122378, 8/14.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Novartis Consumer Health
Reason for Recall:
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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; 10118376, 7/14; 10118377, 7/14; 10118378, 7/14; 10122379, 8/14; 10122382, 10/14 and 10126770, 10/14. 6) WALMART BRAND, Equate, Allergy Relief, Loratadine Lot code and Exp date: 10 ct blister packs 10098127, 9/13; 10099648, 10/2013; 10099649, 10/13; 10101298, 11/13; 10101303, 11/13; 10103516, 12/13; 10106234, 12/13; 10106238, 1/14; 10107028, 1/14; 10109436, 2/14; 10109437, 2/14; 10109863, 2/14; 10109864, 2/14; 10111297, 3/14 and 10111298, 3/14. 30 ct blister pack 10098127, 9/13; 10099647, 9/13; 10099650, 10/13; 10101299, 11/13; 10103513, 11/13; 10103517, 12/13; 10106235, 12/13; 10107029, 1/14; 10107031, 2/14; 10109434, 2/14; 10109437, 2/14; 10109862, 2/14; 10111297, 3/14; 10111299, 3/14; 10111300, 3/14; 10112220, 3/14; 10112221, 3/14; 10114569, 4/14; 10116504, 5/14; 10116506, 6/14; 10118374, 6/14; 10118376, 7/31/2014 and 10118378, 7/14. 7) CVS Pharmacy, Allergy Relief Lot Code and Exp date: 5 ct blister pack 10101298, 11/13; 10106235, 12/13; 10109434, 2/14; 10109864, 2/14; 10112224, 4/14; 10114572, 4/14; 10116504, 5/14 and 10118374, 6/14. 10 ct blister packs: 10099646, 9/13; 10103516, 12/13; 10106238, 1/14; 10109434, 2/14; 10109863, 2/14; 10112221, 3/14 and 10118374, 6/14. 20 ct blister packs: 10099646, 9/13; 10099649, 10/13; 10103516, 12/13; 10106238, 1/14; 10107030, 2/14 and 10111297, 3/14. 10 + 10 ct blister pack: 10106234, 12/13. 30 ct blister packs: 10098127, 9/13; 10099646, 9/13; 10101298, 11/13; 10101302, 11/13; 10103517, 12/13; 10106235, 12/13; 10107028, 1/14; 10107031, 2/14; 10109864, 2/14; 10114573, 5/14 and 10118374, 6/14. 120 ct bottles: 10107028, 1/14 and 10109861, 2/14. 365 ct bottles: 10099647, 9/13; 10101297, 10/13; 10103515, 12/13; 10109860, 2/14; 10114569, 4/14; 10116505, 5/14 and 10122378, 8/14.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-022-2014

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