Reported May 10, 2017 · Terminated

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels:…

P & L Development, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: P & L Development, LLC · 200 Hicks St · Westbury, NY · 11590-3323

Is this the product you have?

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels

5 of 5 products

Products covered by this recall
Model / numberProduct as published
0-36800-39134-5(a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24
3-59726-72025-0(b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072
0-75450-12369-2(c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24
3-59726-72025-0(d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24
8-83967-39839-3.(e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24
Lot codes and dates

5 of 5 products

Products covered by this recall
#Product as published
1A01542, A03660, A04300, A04930, Exp 03/19; A05484, A07951, A12448, Exp 07/19; Y93105, Exp 02/19
2A04938, Exp 03/19; A08149, A12621, Exp 07/19
3A06557, A13030, Exp 03/19
4A00239, 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
5A07871, A11374, Exp 03/19; A14370, A18467, Exp 07/19.
Amount recalled
369,012 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 18, 2019 · Data as of Sep 19, 6:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.