RecallRadar

FDA Drug recall D-0525-2016

Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perri…

On 2015-12-30 the FDA classified a Class III recall of Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perri… by Perrigo, citing failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0525-2016
ClassificationClass III
Statusterminated
Initiated2015-09-28
Published2015-12-30
Last updated2026-09-13 11:51 UTC
CompanyPerrigo
DistributionUS

Product

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)

Reason

Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester

Identifiers

upc370030659432
upc041190223343
upc370030677689
upc015400121026
ndc41163-458-39
ndc41163-458-66
ndc41163-458-72
ndc41163-458-76
ndc41163-458-95
ndc41163-458-58
ndc24385-998-74
ndc24385-998-65
ndc24385-998-75
ndc24385-998-58
ndc55910-699-66
ndc42507-458-30
ndc42507-458-39
ndc42507-458-66
ndc42507-458-60
ndc42507-458-72
ndc42507-458-45
ndc42507-458-95
ndc42507-458-90
ndc42507-458-75
ndc42507-458-06
ndc42507-458-00
ndc42507-458-87
ndc59779-458-13
ndc59779-458-39
ndc59779-458-95
ndc59779-458-75
ndc59779-458-76
ndc59779-458-88
ndc59779-458-66
ndc59779-458-72
ndc59779-458-70
ndc59779-458-58
ndc59779-458-06
ndc59779-458-00
ndc59779-458-05
ndc59779-458-01
ndc36800-458-13
ndc36800-458-66
ndc36800-458-39
ndc36800-458-95
ndc36800-458-72
ndc36800-458-75
ndc36800-458-47
ndc36800-458-87
ndc36800-458-06
ndc36800-458-58
ndc37808-458-66
ndc3700306594
ndc49738-458-66
ndc30142-458-66
ndc49781-106-14
ndc55316-458-66
ndc21130-458-66
ndc0363-0495-66
ndc46994-458-66
ndc41520-458-66
ndc41190-458-66
ndc0411902233
ndc37012-458-66
ndc3700306776
ndc55312-458-66
ndc0154001210
code_info
Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811;…Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377

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-0525-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.