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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 October 2026.

37,239
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,844
Class I recallsReasonable probability of serious health consequences
24,383
Class II recallsTemporary or medically reversible health consequences
2,897
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 2,084 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)

  • 1,739 recalls have been announced year to date.
  • Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (300).
  • 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 II24,383
Class I9,844
Class III2,897
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,383
Class I9,844
Class III2,897
Not Yet Classified2

Showing 19,401–19,420 of 19,975 recalls

FDA Recall TerminatedTerminated: June 9, 2014Historical recordClass III

Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.

by Warner Chilcott Company LLC

Reason
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Published
May 8, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 9, 2014Historical recordClass III

Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866

by Warner Chilcott Company LLC

Reason
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Published
May 8, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: May 13, 2016Historical recordClass III

Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Published
May 8, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 23, 2013Historical recordClass II

Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90

by Jubilant Cadista Pharmaceuticals Inc.

Reason
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Published
May 8, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 22, 2013Historical recordClass II

Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.

by OPMX, LLC

Reason
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 22, 2013Historical recordClass II

Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.

by OPMX, LLC

Reason
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 13, 2014Historical recordClass II

GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.

by Qualitest Pharmaceuticals

Reason
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 3, 2014Historical recordClass II

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

by Hospira Inc.

Reason
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Sterility Assurance
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

View recall →

FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

View recall →

FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Published
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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.