CLASS III Drug recall · Reported 30 Dec 2015 · FDA Enforcement Report
Cetirizine HCl, sold over the counter under the following recalled
Perrigo is recalling Cetirizine HCl, sold over the counter under the following brands, GoodSense, distributed nationwide in the US. The recall was initiated on 28 Sep 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0525-2016
- FDA event ID
- 72505
- Recalling firm
- Perrigo, Allegan, MI
- Manufacturer
- United Natural Foods, Inc. dba UNFI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Sep 2015
- FDA classified
- 24 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 28 Sep 2015 | Recall initiated by company | |
| 24 Dec 2015 | Classified by FDA | +87 days |
| 30 Dec 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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)
Where it was distributed
Nationwide
Stores named: Kroger, H-E-B, Albertsons, Walgreens, CVS, Hy-Vee
Questions about this recall
Why was it recalled?
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Which lots are affected?
Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Perrigo
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Pain & Fever Acetaminophen recalled by Perrigo Company | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal | Perrigo | Manufacturing (CGMP) Deviations | Nationwide |
Other Cetirizine recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |