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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 4,521–4,540 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Recall initiated
October 22, 2021
Reported by FDA
January 12, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645

by RemedyRePack Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
December 29, 2021
Reported by FDA
January 12, 2022
Distribution
Product was distributed to two direct accounts in MI and PA.

View recall →

Drug Recall Terminated Historical recordClass II

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

by Ascend Laboratories, LLC

Reason
Failed impurities/degradation specifications
Recall initiated
December 21, 2021
Reported by FDA
January 12, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01

by Lupin Pharmaceuticals Inc.

Reason
Out-of-specification impurity test result observed at 18-month long term stability time point.
Recall initiated
December 29, 2021
Reported by FDA
January 12, 2022
Distribution
Product Distributed in NY and OH.

View recall →

Drug Recall Terminated Historical recordClass II

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,

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, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4

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

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

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 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

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

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

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

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, Made in the 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

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,

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

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 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the 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

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

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

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

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

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

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

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

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

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

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

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 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

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 Meijer Distribution Inc, Grand Rapids, MI 49544.

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

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

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 →

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.