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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 September 2026.

37,115
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
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 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)

  • 1,527 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 8,081–8,100 of 17,327 recalls

FDA Recall Terminated Historical recordClass II

Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.

by Synthetopes Inc

Reason
Lack of Processing Controls.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32

by Heritage Pharmaceuticals, Inc.

Reason
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31

by Heritage Pharmaceuticals, Inc.

Reason
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.

by Bausch & Lomb

Reason
Failed Stability Specifications: Out of specification for viscosity.
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

by Fresenius Kabi USA, LLC

Reason
Failed Impurities/Degradation Specifications.
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.

by B. Braun Medical Inc

Reason
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.

by Chiesi USA, Inc.

Reason
Failed Dissolution Specifications: Out of specification result for dissolution.
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.

by Chiesi USA, Inc.

Reason
Failed Dissolution Specifications: Out of specification result for dissolution.
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Published
June 19, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846

by Pharm D Solutions, LLC

Reason
Lack of Sterility Assurance.
Published
June 19, 2019
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.