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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Perrigo Allergy Relief Fexofenadine Tablets Recalled for Impurities

Agency Publication Date: January 4, 2022
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Summary

Perrigo Company PLC is recalling approximately 1,002,556 units of various store-brand Fexofenadine Hydrochloride (Allergy Relief) tablets in 60 mg and 180 mg strengths. The recall was initiated after stability testing revealed that the products failed to meet specifications for a specific impurity known as Impurity A. These over-the-counter antihistamines were sold under numerous brand names including Kirkland, Wal-Fex, up&up, and Amazon basic+care at major retailers nationwide.

Risk

The products were found to contain levels of an impurity that exceed approved safety and quality limits, which could potentially affect the medication's safety or effectiveness over time. No injuries or adverse health incidents have been reported to date in connection with this recall.

What You Should Do

  1. This recall affects multiple brands of Fexofenadine Hydrochloride tablets, including Meijer, Publix, Rite Aid, TopCare, up&up (Target), Wal-Fex (Walgreens), Amazon basic+care, Kirkland Aller-Fex (Costco), CVS, GoodSense, Equaline, Berkley Jensen, CareOne, DG Health, Health Mart, H.E.B., Kroger, and Major Pharmaceuticals.
  2. Because this recall includes dozens of different brand names, package sizes, and lot numbers, you should check your medication bottle's brand name and strength (12-hour 60mg or 24-hour 180mg) against the list of identifiers. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Meijer Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
760236187165
760236187172
760236187325
Lot Numbers:
0HE2530 (Exp 12/31/2021)
0KE2430 (Exp 2/28/2022)
0LR0362 (Exp 6/30/2022)
1BR0462 (Exp 10/31/2022)
0FR0460 (Exp 2/28/2022)
NDC:
41250-060-22
41250-060-39
41250-060-95

15, 30, and 45 count bottles.

Product: Publix Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
041415389731
041415387737
Lot Numbers:
0JE2407 (Exp 2/28/2022)
1BR0463 (Exp 10/31/2022)
NDC:
56062-571-22
56062-571-95

15 and 45 count bottles.

Product: Perrigo Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
345802571786
Lot Numbers:
0FR0563 (Exp 02/28/22)
0GR0530 (Exp 03/31/22)
0KR0434
0KR0435
0LR0366
0LR0367
0LR0368 (Exp 06/30/22)
NDC:
45802-571-78

100 count bottle.

Product: Perrigo Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
345802425782
Lot Numbers:
0CR0510 (Exp 09/30/21)
0GR0445 (Exp 01/31/22)
0LR0361 (Exp 04/30/22)
1AR0558 (Exp 07/31/22)
NDC:
45802-425-78

100 count bottle.

Product: Rite Aid Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
011822854108
Lot Numbers:
0JE2487 (Exp 01/31/2022)
0ME2515 (Exp 04/30/2022)
NDC:
11822-0425-0

24 count bottle.

Product: Rite Aid Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
011822999083
011822854115
Lot Numbers:
1BR0462 (Exp 10/31/2022)
0GR0528 (Exp 3/31/2022)
0KR0473 (Exp 4/30/2022)
0LR0369 (Exp 6/30/2022)
NDC:
11822-0571-2
11822-0571-5

30 and 150 count bottles.

Product: TopCare Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
036800332843
Lot Numbers:
0LE2178 (Exp 01/31/2022)
NDC:
36800-954-53

12 count bottle.

Product: TopCare Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
036800332775
036800332782
036800332805
036800332829
Lot Numbers:
0KE2429 (Exp 02/28/2022)
0HE2530 (Exp 12/31/2021)
0FR0460 (Exp 02/28/2022)
0GR0531 (Exp 03/31/2022)
0KR0465 (Exp 04/30/2022)
NDC:
36800-319-13
36800-319-22
36800-319-95
36800-319-75

5, 15, 45, and 90 count bottles.

Product: up&up Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
370030623037
370030623013
Lot Numbers:
1AE2334 (Exp 02/28/2022)
1BR0462 (Exp 10/31/2022)
NDC:
11673-571-22
11673-571-39

15 and 30 count bottles.

Product: Wal-Fex Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
311917122670
311917161723
311917122717
Lot Numbers:
0JE2406 (Exp 02/28/2022)
0FR0459 (Exp 02/28/2022)
0KR0465 (Exp 04/30/2022)
NDC:
0363-0600-13
0363-0600-39
0363-0600-75

5, 30, and 90 count bottles.

Product: Wal-Fex Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
311917186252
Lot Numbers:
0KE2447 (Exp 01/31/2022)
0KE2982 (Exp 01/31/2022)
0ME2515 (Exp 04/30/2022)
NDC:
0363-0903-62

24 count bottle.

Product: Amazon basic+care Allergy Fexofenadine Hydrochloride Tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
370030145362
Lot Numbers:
1AR0558 (Exp 7/31/2022)
NDC:
72288-425-78

100 count bottle.

Product: KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
096619987764
Lot Numbers:
0HV1246 (Exp 1/1/2022)
0GV1974 (Exp 2/1/2022)
0GV1459 (Exp 2/1/2022)
0HV1438 (Exp 3/1/2022)
0KV2116 (Exp 5/1/2022)
0KV2117 (Exp 5/1/2022)
0KV2119 (Exp 6/1/2022)
0LV2196 (Exp 6/1/2022)
0MV2203 (Exp 6/1/2022)
0MV2204 (Exp 6/1/2022)
0MV2205 (Exp 6/1/2022)
NDC:
63981-571-48

180 count bottle.

Product: CVS Allergy Relief, Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
050428625644
Lot Numbers:
1DV1855 (Exp 4/1/2022)
NDC:
69842-698-39

30 count bottle.

Product: GoodSense Aller.Ease, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg
UPC Codes:
301130571393
Lot Numbers:
0MV2158 (Exp 6/1/2022)
NDC:
0113-0571-30

30 count bottle.

Product: EQUALINE Aller-Ease Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg
UPC Codes:
041163480674
041163498471
Lot Numbers:
0HE2530 (Exp 12/31/2021)
0KE2980 (Exp 02/28/2022)
0FR0461 (Exp 2/28/2022)
NDC:
41163-571-22
41163-571-01

15 and 70 count bottles.

Product: GoodSense Aller.Ease, Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg
UPC Codes:
301130425627
Lot Numbers:
0JE2487 (Exp 1/31/2022)
0KE2982 (Exp 1/31/2022)

24 count bottle.

Product: Amazon Allergy Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
370030114665
Lot Numbers:
1BR0462 (Exp 10/31/2022)

30 count bottle.

Product: Basic+Care Allergy Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
370030114702
Lot Numbers:
0GR0528 (Exp 03/31/22)
0KR0473 (Exp 04/30/22)
0LR0369 (Exp 06/30/22)
NDC:
0113-7571-47

150 count bottle.

Product: Basic+Care Allergy Fexofenadine Hydrochloride Tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
370030145362
Lot Numbers:
0CR0510 (Exp 9/30/2021)
0LR0361 (Exp 04/30/2022)
NDC:
0113-7425-78

100 count bottle.

Product: Berkley Jensen Allergy Relief, Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
Lot Numbers:
0HV1442 (Exp 3/1/2022)
1CV1619 (Exp 10/1/2022)

150 count bottle.

Product: CareOne Allergy Relief, Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
341520319846
341520319839
Lot Numbers:
0FR0459 (Exp 2/28/2022)
0LR0362 (Exp 6/30/2022)
1BR0462 (Exp 10/31/2022)
0LR0363 (Exp 6/30/2022)
NDC:
41520-229-39
41520-229-95

30 and 45 count bottles.

Product: CVS Allergy Relief, Fexofenadine Hydrochloride Tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
050428254141
050428534359
Lot Numbers:
0ME2516 (Exp 4/30/2022)
0ME2515 (Exp 4/30/2022)
0KE2982 (Exp 1/31/2022)
NDC:
59779-425-53
59779-425-62

12 and 24 count bottles.

Product: DG Health Aller.Ease, Fexofenadine Hydrochloride Tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
370030657797
Lot Numbers:
0KE2979 (Exp 2/28/2022)
0ME2088 (Exp 2/28/2022)

10 count bottle.

Product: Health Mart, Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
052569142783
Lot Numbers:
0JE2491 (Exp 1/31/2022)
NDC:
62011-0413-1

12 count bottle.

Product: Health Mart, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
052569137871
Lot Numbers:
0FR0461 (Exp 2/25/2022)
NDC:
62011-0233-1

70 count bottle.

Product: H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
041220530809
Lot Numbers:
0JE2491 (Exp 01/31/2022)
0LE2178 (Exp 01/31/2022)
0ME2516 (Exp 4/30/2022)
NDC:
37808-425-53

12 count bottle.

Product: H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 24HR, 180 mg, Antihistamine
UPC Codes:
041220530816
041220530823
041220530830
Lot Numbers:
0HE2530 (Exp 12/31/2021)
0JE2407 (Exp 2/28/2022)
1BR0462 (Exp 10/31/2022)
0FR0460 (Exp 2/28/2022)
0LR0363 (Exp 6/30/2022)
NDC:
37808-571-22
37808-571-39
37808-571-95

15, 30, and 45 count bottles.

Product: Kroger Allergy Relief, Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
041260355882
Lot Numbers:
0LE2178 (Exp 1/31/2022)
0ME2516 (Exp 4/30/2022)
NDC:
30142-555-53

12 count bottle.

Product: Major Fexofenadine Hydrochloride tablets
Variants: 12HR, 60 mg, Antihistamine
UPC Codes:
309046979609
Lot Numbers:
0GR0445 (Exp 1/31/2022)
0LR0361 (Exp 4/30/2022)
1AR0558 (Exp 7/31/2022)
NDC:
0904-6979-60

100 count bottle.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88384
Status: Resolved
Manufacturer: Perrigo Company PLC
Sold By: Meijer; Publix; Rite Aid; TopCare; Target; Walgreens; Amazon.com; Costco; CVS; GoodSense; Equaline; Berkley Jensen; CareOne; DG Health; Health Mart; H.E.B.; Kroger; Major Pharmaceuticals
Manufactured In: Czech Republic
Units Affected: 30 products (55,032 units; 36,048 containers; 32,232 containers; 28,320 containers; 62,568 containers; 7,670 containers; 28776 containers; 138,144 containers; 24,912 containers; 12,384 containers; 6,960 containers; 26,304 containers; 13,920 containers; 48,816 containers; 65,796 containers; 4536 containers; 2280 containers; 89,664 containers; 41,472 containers; 79,776 containers; 44,688 containers; 26,304 containers; 13,656 containers; 7,272 containers; 14,160 containers; 4,536 containers; 38,352 bottles; 42,026 containers; 2,784 bottles; 3,168 bottles)
Distributed To: Nationwide
Agency Last Updated: May 31, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.