P & L Development Recalls Subpotent Diphenhydramine HCl Allergy Softgels
P & L Development is recalling 369,012 cartons of diphenhydramine HCl allergy softgels sold under multiple brands due to low potency test results.
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 III, which indicates a low risk of adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety threat like toxicity or contamination, fitting the criteria for a moderate severity score.
Plain-English summary
P & L Development, LLC is recalling 369,012 cartons of Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels. The product was distributed nationwide under five different labels: TopCare Allergy Relief, Rexall Since 1903 Allergy Relief, HyVee health Allergy Relief, up & up allergy relief, and smart sense allergy softgels.
The recall was initiated because the product failed to meet potency specifications, specifically showing low assay results at the 9-month time point. This means the medication may not contain the full amount of the active ingredient required to be effective.
Consumers who have purchased these products should check their lot numbers and expiration dates against the list provided by the FDA. If the product matches the recalled lots, consumers should stop using it and return it to the place of purchase for a refund or contact the recalling firm for instructions.
The recalled product
- Product
- Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Aller
- Manufacturer
- P & L Development, LLC
- Category
- Drug — Antihistamine
- Affected units
- 369,012
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 (20)
- Lot #: a) A01542
- A03660
- A04300
- A04930
- Exp 03/19
- A05484
- A07951
- A12448
- Exp 07/19
- Y93105
- Exp 02/19
- b) A04938
- A08149
- A12621
- c) A06557
- A13030
- d) A00239
- A05180
- A09906
- Y83246
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · subpotent
See all →- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- HighCompounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services
FDA (Drugs) · 2026-06-24
- ModerateSkin Rehab calming hydrocortisone balm recalled as a subpotent drug
FDA (Drugs) · 2026-04-22
- Moderateglo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
- ModerateRhonda Allison calming skin gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22