The Recall Desk
ModerateFDA (Drugs)·D-0525-2016·Announced 2015-12-30

Perrigo Recalls Equaline All Day Allergy Tablets Due to Impurity

Perrigo is recalling Equaline All Day Allergy tablets because they contain an impurity called cetirizine monosaccharide ester.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a chemical impurity without reported injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Perrigo Company PLC is recalling 209,256 cartons of Equaline All Day Allergy (Cetirizine Hydrochloride) 10 mg tablets. The recall was initiated because the product failed impurity and degradation specifications, with the specific impurity identified as cetirizine monosaccharide ester.

The affected product is sold over the counter in 14-count blister packs under multiple store brands, including GoodSense, Good Neighbor Pharmacy, HEB, Rexall, HyVee, Smart Sense, Kroger, Leader, CVS Pharmacy, Healthy Accents, Safeway Care, Topcare, Wal-Zyr, Being Well, CareOne, Shoprite, Shopko, and Western Family. The recall covers batches with an expiration date of 05/16 and specific batch codes listed in the recall notice.

Consumers who have purchased these products should stop using them and return them to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product
EQUALINE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE)
Brand
EQUALINE ALL DAY ALLERGY
Affected units
209,256

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Batches: Exp 05/16: 4GE1457
  • 4GE1500
  • 4GE1819
  • 4GE1893
  • 4HE1255
  • 4HE1396
  • 4HE1620
  • 4HE1656
  • 4HE1811
  • 4JE1035
  • 4JE1212
  • 4JE1324
  • 4JE1513
  • and 4KE1377

UPCs (4)

  • 370030659432
  • 041190223343
  • 370030677689
  • 015400121026

Distribution

Distributed nationwide across the United States.