The Recall Desk
ModerateFDA (Drugs)·D-1451-2022·Announced 2022-08-31

CLARITIN Allergy Products Recalled Due to Improper Storage Conditions

Family Dollar Stores is recalling specific CLARITIN allergy products (liquids and tablets) distributed from April through June 2022 due to improper storage temperature conditions that may affect product quality.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard involves improper storage temperature, which is a manufacturing and quality-based deviation rather than evidence of actual consumer harm, meeting the criteria for Moderate severity.

Plain-English summary

Family Dollar Stores, LLC is recalling multiple CLARITIN allergy products sold at specific Family Dollar Store locations. The recalled products include CLARITIN Allergy Liquid Children's Grape (2 fl oz, SKU 900834), CLARITIN Allergy 10 mg Tablets in 5-count and 10-count packages (SKUs 916116 and 901655), and GS Allergy Loratadine Tablets 30-count (SKU 916114).

The products are being recalled due to a Current Good Manufacturing Practice (CGMP) deviation: they were held outside appropriate storage temperature conditions. Improper storage temperatures may affect product quality and effectiveness.

The affected products were distributed to specific Family Dollar Stores nationwide between April 30, 2022 and June 10, 2022. Consumers who purchased these products should stop using them and contact Family Dollar Stores with any questions or concerns.

The recalled product

Product
CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Manufacturer
Family Dollar Stores, Llc.
Hazard
  • temperature-deviation
  • improper-storage

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 (4)

  • SKUs: 900834
  • 916116
  • 916114
  • 901655

Distribution

Distributed nationwide across the United States.