Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4551–4575 of 17964

ModerateFDA (Drugs)·D-0355-2022·2022-01-12
Kirkland Aller-Fex tablets recalled for impurity specification failure
Perrigo Company is recalling Kirkland Aller-Fex fexofenadine hydrochloride 180 mg tablets nationwide because stability testing found out-of-specification impurity levels in affected lots.
Product
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, U
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0348-2022·2022-01-12
Rite Aid Allergy Relief Fexofenadine tablets recalled for impurity
Perrigo Company PLC is recalling Rite Aid Allergy Relief Fexofenadine Hydrochloride 180mg tablets nationwide due to failed impurity specifications. An out-of-specification result for impurity A was found during stability testing.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0326-2022·2022-01-12
Gatifloxacin Ophthalmic Solution Recall Due to Failed Stability Testing
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.
Product
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.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0327-2022·2022-01-12
Pain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures
ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.
Product
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
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0350-2022·2022-01-12
TopCare Allergy Relief Fexofenadine tablets recalled for impurity specifications
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0344-2022·2022-01-12
Allergyrelief Fexofenadine Tablets Recalled for Impurity Specification Failure
Perrigo Company is recalling allergyrelief Fexofenadine Hydrochloride 24HR tablets due to an out-of-specification result for impurity A detected during stability testing.
Product
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 Lak
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0343-2022·2022-01-12
Meijer Fexofenadine Hydrochloride Allergy Relief Tablets Recalled
Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0347-2022·2022-01-12
Rite Aid Allergy Relief Fexofenadine Tablets Recalled for Impurity
Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0328-2022·2022-01-12
EQUALINE Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Testing
Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.
Product
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.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0361-2022·2022-01-12
Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects
Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.
Product
PREGABALIN — PREGABALIN (PREGABALIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0342-2022·2022-01-12
MAJOR Fexofenadine Hydrochloride 60mg tablets recalled for failed impurity specifications
Perrigo Company PLC is recalling MAJOR brand Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets due to failed impurities and degradation specifications detected during stability testing.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0352-2022·2022-01-12
Wal-Fex Fexofenadine Hydrochloride Tablets Recalled for Impurity Specification Failure
Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg tablets distributed nationwide because impurity A levels exceeded specifications during stability testing.
Product
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 Walgree
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0341-2022·2022-01-12
Kroger Allergy Relief Fexofenadine Tablets Recalled for Impurity
Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0337-2022·2022-01-12
Health Mart Fexofenadine Tablets Recalled for Failed Impurity Specifications
Perrigo Company PLC is recalling Health Mart Fexofenadine Hydrochloride 12HR 60mg tablets due to impurity A exceeding specification limits during stability testing. The recall affects 12,384 containers distributed nationwide.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0340-2022·2022-01-12
H.E.B Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications
H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.
Product
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; Ma
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0351-2022·2022-01-12
Up&Up Allergy Relief 180mg Tablets Recalled for Failed Impurity Specification
Perrigo Company PLC is recalling up&up allergy relief fexofenadine hydrochloride 180mg tablets distributed nationwide because stability testing found impurity A exceeded specifications. The affected products are 15-count and 30-count bottles with specific lot numbers and expiration dates.
Product
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 Re
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0359-2022·2022-01-12
Cefixime Capsules 400 mg Recalled for Failed Impurities and Degradation
Ascend Laboratories recalls Cefixime 400 mg capsules due to failed impurities and degradation specifications. The affected 42,698 bottles were distributed nationwide.
Product
CEFIXIME — CEFIXIME (CEFIXIME)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0357-2022·2022-01-12
GoodSense Aller.Ease Fexofenadine Recalled for Impurity Specification
Perrigo Company PLC is recalling GoodSense Aller.Ease Fexofenadine hydrochloride 180 mg tablets nationwide due to an out-of-specification impurity detected during stability testing.
Product
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,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0336-2022·2022-01-12
DG/health Aller.Ease Fexofenadine Tablets Recalled for Impurity
Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications during stability testing.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0360-2022·2022-01-12
Cefixime 400 mg Capsules Recalled for Failed Impurities and Degradation Specifications
RemedyRepack Inc. is recalling Cefixime 400 mg capsules distributed in Michigan and Pennsylvania due to failed impurities and degradation specifications. The affected products may not meet established quality and safety standards.
Product
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
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0335-2022·2022-01-12
CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity
CVS Allergy Relief Fexofenadine Hydrochloride Tablets 60 mg are being recalled because stability testing found an out-of-specification result for impurity A. The recall affects approximately 138,144 containers distributed nationwide.
Product
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 02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0346-2022·2022-01-12
Perrigo Fexofenadine Hydrochloride Tablets Recall for Impurity Contamination
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 60mg antihistamine tablets (100-count bottles) nationwide due to failed impurity specifications found during stability testing. The recall affects 41,472 containers distributed in the USA.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0329-2022·2022-01-12
GoodSense Aller.Ease fexofenadine tablets recalled for impurity specification failure
Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified during stability testing.
Product
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.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0331-2022·2022-01-12
Perrigo basic+care Fexofenadine Tablets Recall—Failed Impurity Specifications
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets (180 mg, 150-count bottles) distributed nationwide because impurity testing results exceeded specification limits during stability testing.
Product
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0358-2022·2022-01-12
Oxycodone Hydrochloride Tablets Recalled for Out-of-Specification Impurity
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.
Product
OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Category
Drug
Distribution
2 states

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4551–4575 of 17964