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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 4,541–4,560 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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 TX 78204, Product of Czech Republic,

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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 Republic

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

by Perrigo Company PLC

Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated
July 27, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

by ULTRAtab Laboratories, Inc.

Reason
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Recall initiated
November 29, 2021
Reported by FDA
January 12, 2022
Distribution
Product was distributed to one customer who may have further distributed the product.

View recall →

Drug Recall Terminated Historical recordClass III

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

by Lupin Pharmaceuticals Inc.

Reason
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Recall initiated
December 22, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1

by Valisa MFG LLC

Reason
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Recall initiated
December 6, 2021
Reported by FDA
January 5, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 12, 2021
Reported by FDA
January 5, 2022
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 12, 2021
Reported by FDA
January 5, 2022
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 12, 2021
Reported by FDA
January 5, 2022
Distribution
U.S.A. Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.