FDA Drug recall D-0694-2017
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy…
- FDA Drug
- Class III
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class III recall of Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy… by P And L Development, citing subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0694-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-04-17 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | P And L Development |
| Distribution | US |
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
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Identifiers
| upc | 036800391345 |
|---|---|
| upc | 359726720250 |
| upc | 075450123692 |
| upc | 883967398393 |
| code_info | Lot #: a) A01542, A03660, A04300, A04930, Exp 03/19; A05484, A07951, A12448, Exp 07/19; Y93105, Exp 02/19; b) A04938,…Lot #: a) A01542, A03660, A04300, A04930, Exp 03/19; A05484, A07951, A12448, Exp 07/19; Y93105, Exp 02/19; b) A04938, Exp 03/19; A08149, A12621, Exp 07/19; c) A06557, A13030, Exp 03/19; d) A00239, Exp 03/19; A05180, A09906, Exp 07/19; Y83246, Y87531, Y87680, Exp 08/18; Y91225, Y92670, Y98200, Y98674, Exp 02/19; A13354, Exp 07/19; e) A07871, A11374, Exp 03/19; A14370, A18467, Exp 07/19. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0694-2017%22
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