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Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026)

Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026)

Drug Recall

Official source record

Recall number: D-0525-2016
Event ID: 72505
Classification: Class III
Status: Terminated
Recalling company: Perrigo Company PLC
Reason for recall: Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Report date: December 30, 2015
Recall initiation date: September 28, 2015
Termination date: March 22, 2016
Distribution pattern: Nationwide

Drug product identifiers

Manufacturer: Amerisource Bergen; CVS Pharmacy; Dolgencorp, LLC; HyVee Inc; Topco Associates LLC; United Natural Foods, Inc. dba UNFI
Brand names: ALL DAY ALLERGY; ALLERGY RELIEF; EQUALINE ALL DAY ALLERGY; GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY; REXALL ALL DAY ALLERGY RELIEF; TOPCARE ALL DAY ALLERGY
Generic name: CETIRIZINE HYDROCHLORIDE
Substance name: CETIRIZINE HYDROCHLORIDE
Product NDCs: 24385-998; 36800-458; 41163-458; 42507-458; 55910-699; 59779-458
Package NDCs: 0154001210; 0363-0495-66; 0411902233; 21130-458-66; 24385-998-58; 24385-998-65; 24385-998-74; 24385-998-75; 30142-458-66; 36800-458-06; 36800-458-13; 36800-458-39; 36800-458-47; 36800-458-58; 36800-458-66; 36800-458-72; 36800-458-75; 36800-458-87; 36800-458-95; 3700306594; 3700306776; 37012-458-66; 37808-458-66; 41163-458-39; 41163-458-58; 41163-458-66; 41163-458-72; 41163-458-76; 41163-458-95; 41190-458-66; 41520-458-66; 42507-458-00; 42507-458-06; 42507-458-30; 42507-458-39; 42507-458-45; 42507-458-60; 42507-458-66; 42507-458-72; 42507-458-75; 42507-458-87; 42507-458-90; 42507-458-95; 46994-458-66; 49738-458-66; 49781-106-14; 55312-458-66; 55316-458-66; 55910-699-66; 59779-458-00; 59779-458-01; 59779-458-05; 59779-458-06; 59779-458-13; 59779-458-39; 59779-458-58; 59779-458-66; 59779-458-70; 59779-458-72; 59779-458-75; 59779-458-76; 59779-458-88; 59779-458-95
Route: ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

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Retrieved by Public Health Trace: July 28, 2026 ET

Frequently asked questions

What does a Class III mean?

A situation in which use of or exposure to a product is not likely to cause adverse health consequences.

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