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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 19,421–19,440 of 19,975 recalls

FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

BiMix Standard 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

Mono-mix (Prostaglandin) 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

Comprehensive injection #4 - SS varied injectable 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

Phosphatidylcholine 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

Cyclosporin (Grapeseed Oil) Ophthalmic 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

Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium 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

Methylcobalamin and Folic Acid 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

Cyanocobalamin (CMP) 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 Hexacetonide 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

Betamethasone 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 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

Methylprednisolone Acetate 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

TriMix Standartd (PGE Stock Sol'n) 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: December 5, 2013Historical recordClass III

Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10

by Mylan Pharmaceuticals Inc.

Reason
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 26, 2014Historical recordClass II

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

by Sandoz Incorporated

Reason
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 14, 2013Historical recordClass I

WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.

by Brower Enterprises Inc

Reason
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Published
May 1, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 19, 2017Historical recordClass II

Trimix 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: June 5, 2013Historical recordClass I

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

by Body Basics Inc

Reason
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Published
April 24, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 11, 2013Historical recordClass III

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.

by Lupin Pharmaceuticals Inc.

Reason
Discoloration; Product may not meet specifications for color description once reconstituted.
Published
April 24, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: August 21, 2015Historical recordClass I

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.

by Hospira Inc.

Reason
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Published
April 24, 2013
Distribution
Nationwide

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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.