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Recall totals

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

37,205
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).
  • 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 II24,366
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 14,681–14,700 of 23,259 recalls

FDA Recall Terminated Historical recordClass I

Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

by Baxter Healthcare Corporation

Reason
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Tiger King tablets, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass II

MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass II

STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass II

Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass II

HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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FDA Recall Terminated Historical recordClass I

Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Published
February 7, 2018
Distribution
NY and NJ through six retail stores name…

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.