Allergy Relief Diphenhydramine HCl 25mg Softgels Recall: Subpotent Product Risk
P & L Development recalls 24-count Allergy Relief diphenhydramine softgels due to low potency at 9 months. This may reduce effectiveness but does not pose immediate safety risks.
Lower-risk recall
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Contact the company
What happened, in plain English
P & L Development is recalling 24-count Allergy Relief diphenhydramine softgels because lab tests showed lower-than-expected potency after 9 months. This means the medication might not work as well over time, but it does not cause immediate health risks. Read more at govinfonow.com/recall/41754-allergy-relief-diphenhydramine-hcl-25mg-softgels-recall-subpotent-product-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41754-allergy-relief-diphenhydramine-hcl-25mg-softgels-recall-subpotent-product-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0694-2017
Cite this page
“Allergy Relief Diphenhydramine HCl 25mg Softgels Recall: Subpotent Product Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41754-allergy-relief-diphenhydramine-hcl-25mg-softgels-recall-subpotent-product-risk. Based on FDA recall #D-0694-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0694-2017%22&limit=1).
Why it’s dangerous
The product was found to have lower-than-expected potency at the 9-month mark during quality testing. This means the medication may not work as effectively over time, but it does not cause immediate health hazards.
Who’s affected
People who purchased these allergy relief softgels from retailers like Target, Kmart, or HyVee. Those with allergies who rely on this medication for relief are most at risk of reduced effectiveness.
How to tell if you have this one
Check for the product labels: TopCare Allergy Relief, Rexall Since 1903 Allergy Relief, HyVee health Allergy Relief, up & up allergy relief, or smart sense allergy softgels. Look for specific lot numbers and expiration dates listed in the recall notice.
- Brand
P & L Development- Product
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels- Category
Drug
What to do — step by step
Check Product Labels
Identify the product by checking the label for the brand name and lot number listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0694-2017 (April 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0694-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.