Allergy Relief Diphenhydramine HCl 25 mg — Class III drug recall D-0694-2017
Terminated recall by P & L Development, LLC, reported 2017-05-10, distributed nationwide. Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time po
| Recall number | D-0694-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | P & L Development, LLC, Westbury, NY, United States |
| Recall initiated | 2017-04-17 |
| Classified | 2017-05-02 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 369,012 cartons |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00036800391345, 00075450123692, 00359726720250, 00883967398393 |
| NDC | 11673-0720-24, 36800-0483-24, 42507-0483-24, 49738-0483-24 |
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 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
Reason for recall
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0694-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.