LowClass IIITerminated

FDA Drug recall · Reported December 30, 2015

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, d

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

Recall #: D-0525-2016
Affected scope: 209,256 cartons
Initiated: September 28, 2015

Compiled from official public sources by the editorial team. · Updated July 2026

Perrigo Company PLC recalled Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the foll… - a low-severity action.

Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the foll… was recalled by Perrigo Company PLC in December 30, 2015. Reason: Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester. Check the official notice for the remedy. Verify recall #D-0525-2016 with the FDA Drug before acting.

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The recall

Perrigo Company PLC issued this low-severity FDA Drug recall-Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester.

Low
severity level: Class III
classification: December 30, 2015
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0525-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0525-2016) was formally reported on December 30, 2015, with the manufacturer initiating the action on September 28, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Perrigo Company PLC is listed as the recalling firm, operating out of Allegan, MI. Federal records list the affected scope as 209,256 cartons.

The documented reason for this recall is: Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

209,256 cartons

Related Recalls

0 from same agency

Product description

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-0525-2016
Date reported	December 30, 2015
Date initiated	September 28, 2015
Recalling firm	Perrigo Company PLC
Firm location	Allegan, MI
Affected scope	209,256 cartons
Distribution	Nationwide

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0525-2016) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on December 30, 2015. Severity: Low. Recall number: D-0525-2016.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (D-0525-2016) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 30, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.