CLASS II Drug recall · Reported 3 Jul 2013 · FDA Enforcement Report
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg recalled
Kareway Product is recalling Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively, distributed nationwide in the US. The recall was initiated on 3 May 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-620-2013
- FDA event ID
- 53558
- Recalling firm
- Kareway Product, Compton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2013
- FDA classified
- 26 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 3 May 2013 | Recall initiated by company | |
| 26 Jun 2013 | Classified by FDA | +54 days |
| 3 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Product as listed by the FDA
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
Where it was distributed
Nationwide in the US: CA, OR, WA. Africa.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Which lots are affected?
Lot# 6781202 & 6781302
Where was it sold?
Nationwide in the US: CA, OR, WA. Africa.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.