Drug recall: EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC…

Class II FDA enforcement event 88384. Recall start date: 27 Jul 2021. Status in the FDA record: Terminated. Termination date: 8 Nov 2022.

Reason for recall, in the words of FDA

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Perrigo Company PLC started this drug recall on 27 Jul 2021. The firm address in the FDA record is in Allegan, MI. FDA put the recall in Class II. FDA event 88384 has 30 product records. The first FDA enforcement report date is 12 Jan 2022. The record gives the status Terminated, with the termination date 8 Nov 2022.

FDA enforcement report The 30 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

Perrigo Company PLC, Allegan, MI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

30 product records in the event.

FDA event 88384: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0328-2022	EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.	55,032 units	Class II	Terminated	12 Jan 2022
D-0329-2022	GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.	36,048 containers	Class II	Terminated	12 Jan 2022
D-0330-2022	amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5	32,232 containers	Class II	Terminated	12 Jan 2022
D-0331-2022	basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2	28,320 containers	Class II	Terminated	12 Jan 2022
D-0332-2022	basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2	62,568 containers	Class II	Terminated	12 Jan 2022
D-0333-2022	berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581	7,670 containers	Class II	Terminated	12 Jan 2022
D-0334-2022	CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech…	28776 containers	Class II	Terminated	12 Jan 2022
D-0335-2022	CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, Made in Czech Republic	138,144 containers	Class II	Terminated	12 Jan 2022
D-0336-2022	DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7	24,912 containers	Class II	Terminated	12 Jan 2022
D-0337-2022	Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3	12,384 containers	Class II	Terminated	12 Jan 2022
D-0338-2022	Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1	6,960 containers	Class II	Terminated	12 Jan 2022
D-0339-2022	H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9	26,304 containers	Class II	Terminated	12 Jan 2022
D-0340-2022	H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio…	13,920 containers	Class II	Terminated	12 Jan 2022
D-0341-2022	Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2	48,816 containers	Class II	Terminated	12 Jan 2022
D-0342-2022	MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9	65,796 containers	Class II	Terminated	12 Jan 2022
D-0343-2022	Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made in the Czech Republic, Distributed by…	4536 containers	Class II	Terminated	12 Jan 2022
D-0344-2022	allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lakeland, FL 33811, Made in the Czech…	2280 containers	Class II	Terminated	12 Jan 2022
D-0345-2022	Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6	89,664 containers	Class II	Terminated	12 Jan 2022
D-0346-2022	Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2	41,472 containers	Class II	Terminated	12 Jan 2022
D-0347-2022	Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8	79,776 containers	Class II	Terminated	12 Jan 2022
D-0348-2022	Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011	44,688 containers	Class II	Terminated	12 Jan 2022
D-0349-2022	TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3	26,304 containers	Class II	Terminated	12 Jan 2022
D-0350-2022	TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0…	13,656 containers	Class II	Terminated	12 Jan 2022
D-0351-2022	up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Republic,	7,272 containers	Class II	Terminated	12 Jan 2022
D-0352-2022	Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015,…	14,160 containers	Class II	Terminated	12 Jan 2022
D-0353-2022	Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2	4,536 containers	Class II	Terminated	12 Jan 2022
D-0354-2022	amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2	38,352 bottles	Class II	Terminated	12 Jan 2022
D-0355-2022	KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4	42,026 containers	Class II	Terminated	12 Jan 2022
D-0356-2022	CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4	2,784 bottles	Class II	Terminated	12 Jan 2022
D-0357-2022	GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30,	3,168 bottles	Class II	Terminated	12 Jan 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2021: 299
Share of these events in Class II: 60%
Product records in this event: 30Median of the firm: 2
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Perrigo Company PLC
Initiated	Product (first record)	Type	Class	Records
26 Oct 2021	Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Alleg	Drug	Class II	51
16 Sep 2020	Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma So	Drug	Class II	1
23 Oct 2019	Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-	Drug	Class II	17
20 Jun 2019	Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468	Food	Class II	1
21 Jan 2019	Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt, 113 g, packed in a laminate pouch,	Food	Class II	1
18 Jan 2016	Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05,	Drug	Class II	2
8 Jan 2016	Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under	Drug	Class II	2
28 Sep 2015	Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand d	Drug	Class III	1

Perrigo Company PLC: all 9 events

Official channels

FDA enforcement report D-0328-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 88384. https://recallregister.com/fda/ii/88384/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 88384?: The event has 30 product records. The first record gives this quantity: 55,032 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2021 have the same class?: 60% of the 299 drug events that started in 2021 are in Class II.