The Recall Desk
ModerateFDA (Drugs)·D-620-2013·Announced 2013-07-03

Kareway Recalls Pure-Aid Allergy Relief Caplets Due to Labeling Error

Kareway Products Inc. is recalling Pure-Aid Allergy Relief caplets because the foil label incorrectly lists Chlorpheniramine instead of Diphenhydramine.

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: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

Kareway Products Inc. is recalling 24,048 cartons of Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets. The recall is due to a labeling error where the foil label on the immediate blister pack indicates the active ingredient as Chlorpheniramine rather than Diphenhydramine.

The affected product is identified by Lot numbers 6781202 and 6781302 and UPC 8 56023 00158 2. The product was distributed nationwide in the US, specifically in California, Oregon, and Washington, as well as in Africa.

Consumers should check their inventory for the specific lot numbers and UPC listed above. If they possess the affected product, they should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
Affected units
24,048

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 (1)

  • Lot# 6781202 & 6781302

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: