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Recall totals

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

37,118
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,793
Class I recallsReasonable probability of serious health consequences
24,343
Class II recallsTemporary or medically reversible health consequences
2,887
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 II24,343
Class I9,793
Class III2,887
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1

Showing 8,961–8,980 of 17,229 recalls

FDA Recall Terminated Historical recordClass II

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA

by Medline Industries Inc

Reason
Microbial Contamination of Non-Sterile Product
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356

by Tailor Made Compounding

Reason
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Published
November 14, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.

by Janssen Pharmaceuticals, Inc.

Reason
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59

by Silver Star Brands

Reason
Microbial Contamination of Non-Sterile Products
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10

by Baxter Healthcare Corporation

Reason
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Published
November 14, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.

by Janssen Pharmaceuticals, Inc.

Reason
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Published
November 14, 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.