Reported Dec 30, 2015 · Terminated

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

Perrigo Company PLC

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: Perrigo Company PLC · 515 Eastern Ave · Allegan, MI · 49010-9070

Is this the product you have?

19 of 19 products

Products covered by this recall
Model / numberProduct as published
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)
370030659432Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 ), 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)
041190223343Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 )
370030677689Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 )
015400121026Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 )
Lot codes and dates
  • Batches
    • Exp 05/16: 4GE1457
    • 4GE1500
    • 4GE1819
    • 4GE1893
    • 4HE1255
    • 4HE1396
    • 4HE1620
    • 4HE1656
    • 4HE1811
    • 4JE1035
    • 4JE1212
    • 4JE1324
    • 4JE1513
    • and 4KE1377
Amount recalled
209,256 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

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 Mar 22, 2016 · Data as of Sep 19, 7:10 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.