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Recall totals

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

37,204
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,841
Class I recallsReasonable probability of serious health consequences
24,366
Class II recallsTemporary or medically reversible health consequences
2,892
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 2,073 recalls
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)

  • 1,714 recalls have been announced year to date.
  • Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (297).
Recalls by class

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

Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2

Showing 15,081–15,100 of 18,068 recalls

FDA Recall Terminated Historical recordClass II

Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

by GlaxoSmithkline Consmer Healthcare

Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

by Ranbaxy Inc.

Reason
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37

by Perrigo Israel Pharmaceuticals

Reason
Subpotent drug
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

by Actavis Laboratories, FL, Inc.

Reason
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.

by Shionogi Inc.

Reason
Failed Dissolution Specifications
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Published
August 12, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.

by Boehringer Ingelheim Roxane Inc

Reason
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Published
August 5, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

by Purdue Pharma L.P.

Reason
Failed dissolution specifications
Published
July 29, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 29, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 29, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 29, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Published
July 29, 2015
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.