CLASS III Drug recall · Reported 10 May 2017 · FDA Enforcement Report

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine recalled

P & L Development is recalling Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, distributed under the, distributed nationwide in the US. The recall was initiated on 17 Apr 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 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.

Quantity recalled369,012 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0694-2017
FDA event ID: 77007
Recalling firm: P & L Development, Westbury, NY
Classification: Class III
Status: Terminated
Recall initiated: 17 Apr 2017
FDA classified: 2 May 2017
Reported: 10 May 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Drug class: Allergy Medication

Timeline

17 Apr 2017	Recall initiated by company
2 May 2017	Classified by FDA	+15 days
10 May 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Stores named: Target, Hy-Vee

Questions about this recall

Why was it recalled?

Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

Which lots are affected?

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.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.