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Recall totals

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

37,142
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,799
Class I recallsReasonable probability of serious health consequences
24,349
Class II recallsTemporary or medically reversible health consequences
2,891
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 2,072 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)

  • 1,527 recalls have been announced year to date.
  • Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
  • The highest complete period was Jun 2026 (297).
  • Sep 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 II24,349
Class I9,799
Class III2,891
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,349
Class I9,799
Class III2,891
Not Yet Classified1

Showing 13,381–13,400 of 21,635 recalls

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…

View recall →

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…

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FDA Recall Terminated Historical recordClass III

Indian God Lotion Spray Bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug 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

Black Ant capsules, 4600mg, 4-count blister pack, 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

Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16

by International Laboratories, LLC

Reason
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

by Fresenius Kabi USA, LLC

Reason
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Published
February 7, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Published
February 7, 2018
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.