The Recall Desk
LowFDA (Drugs)·D-022-2014·Announced 2013-12-04

Novartis Recalls Loratadine Tablets Due to Chipped and Broken Pieces

Novartis Consumer Health is recalling 11.8 million loratadine 10 mg antihistamine blister packs sold nationwide under seven different store brands because the tablets are chipped or broken.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The defect is a physical quality issue (chipped/broken tablets) rather than a contamination or mislabeling hazard.

Plain-English summary

Novartis Consumer Health is recalling approximately 11,846,608 blister packs of Loratadine, USP 10 mg, an antihistamine medication. The products were manufactured in Lincoln, Nebraska, and distributed nationwide under seven different retail labels, including Dollar General, Family Dollar, Target, Walmart (Equate), CVS Pharmacy, and a private label. The recall covers various package sizes, ranging from 5-tablet blister packs to 365-tablet bottles.

The recall was initiated because the tablets failed to meet specifications, specifically due to being chipped and broken. The FDA has classified this as a Class III recall, indicating that the defect is unlikely to cause serious adverse health consequences or death. Specific lot numbers and expiration dates for the affected products are listed in the source data.

Consumers who have purchased these products should stop using them and return them to the place of purchase for a refund or contact the manufacturer for further instructions. The recall affects products sold at major retail chains across the United States.

The recalled product

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 Aller
Manufacturer
Novartis Consumer Health
Category
Drug — Antihistamine
Hazard
Affected units
11,846,608

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 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

Distribution

Distributed nationwide across the United States.

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