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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Kareway Product Inc
- Hazard
- 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
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighCORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations
FDA (Drugs) · 2022-09-14
- ModerateAurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures
FDA (Drugs) · 2019-09-25
- HighAllergy Relief Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2023-07-19
- LowDiphenhydramine HCl Capsules Recalled Due to Wrong ID Imprinting
FDA (Drugs) · 2025-01-22
- ModerateCAREONE Allergy Relief 180 mg Tablets Recalled for Failed Impurities Specifications
FDA (Drugs) · 2022-01-12
- HighCareone Allergy Relief tablets recalled for failed impurity and degradation specifications
FDA (Drugs) · 2023-07-19