Cetirizine HCl 10 mg Tablet — Class III drug recall D-0525-2016
Terminated recall by Perrigo Company PLC, reported 2015-12-30, distributed nationwide. Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
| Recall number | D-0525-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Company PLC, Allegan, MI, United States |
| Recall initiated | 2015-09-28 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 209,256 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00015400121026, 00041190223343, 00370030659432, 00370030677689 |
| NDC | 00363-0495-66, 21130-0458-66, 24385-0998, 24385-0998-58, 24385-0998-65, 24385-0998-74, 24385-0998-75, 30142-0458-66, 36800-0458, 36800-0458-06, 36800-0458-13, 36800-0458-39, 36800-0458-47, 36800-0458-58, 36800-0458-66, 36800-0458-72, 36800-0458-75, 36800-0458-87, 36800-0458-95, 37012-0458-66, 37808-0458-66, 41163-0458, 41163-0458-39, 41163-0458-58, 41163-0458-66 and 40 more |
| Lot numbers | 05/16, 4GE1457, 4GE1500, 4GE1819, 4GE1893, 4HE1255, 4HE1396, 4HE1620, 4HE1656, 4HE1811, 4JE1035, 4JE1212, 4JE1324, 4JE1513, 4KE1377 |
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 for recall
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0525-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.