# FDA recall D-0694-2017

> **P & L Development,  LLC** · Class III · drug recall initiated 2017-04-17.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0694-2017
- **Recalling firm:** P & L Development,  LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-17
- **Report date:** 2017-05-10
- **Termination date:** 2019-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Westbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0694-2017

## Citation

> AI Analytics. FDA recall D-0694-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0694-2017. Source: US FDA. Licensed CC0.

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