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Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.

Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to October 2026.

37,239
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,844
Class I recallsReasonable probability of serious health consequences
24,383
Class II recallsTemporary or medically reversible health consequences
2,897
Class III recallsNot likely to cause adverse health consequences

Quick insights

A snapshot of the most notable patterns across all recorded FDA and USDA recalls.

Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap. 53 recalls
Most common hazardLack of Assurance of Sterility 2,084 recalls
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eden-brothers-recalls-calabrese-broccoli-seeds-due-possible-salmonella-contaminationPublished October 7, 2026
Most affected stateHawaii 200 recalls mention this state

Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

Summary (Year to date)

  • 1,739 recalls have been announced year to date.
  • Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (300).
  • Oct 2026 is incomplete and not included in the figures above.
  • Complete data
  • Incomplete
Recalls by class

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,383
Class I9,844
Class III2,897
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,383
Class I9,844
Class III2,897
Not Yet Classified2

Showing 17,681–17,700 of 19,432 recalls

FDA Recall TerminatedTerminated: April 24, 2017Historical recordClass II

Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60

by Pfizer Inc.

Reason
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 31, 2016Historical recordClass I

VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.

by Shire Human Genetic Therapies, Inc.

Reason
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 29, 2016Historical recordClass I

XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box

by Dolphin Intertrade Corporation

Reason
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 29, 2016Historical recordClass I

JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle

by Dolphin Intertrade Corporation

Reason
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 29, 2015Historical recordClass I

RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309

by Fossil Fuel Products, LLC

Reason
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 20, 2017Historical recordClass III

Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.

by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline

Reason
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Published
April 30, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: January 29, 2015Historical recordClass I

Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com

by Haute Health, LLC

Reason
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Published
April 23, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 29, 2015Historical recordClass I

PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.

by Haute Health, LLC

Reason
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Published
April 23, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 29, 2015Historical recordClass I

Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com.

by Haute Health, LLC

Reason
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Published
April 23, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 4, 2014Historical recordClass I

1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.

by Hospira, Inc.

Reason
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Published
April 23, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 2, 2019Historical recordClass I

Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.

by B @ B Trade Inc.

Reason
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Published
April 23, 2014
Distribution
Nationwide

View recall →

Data last updated:

Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.