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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 17,221–17,240 of 19,432 recalls

FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: November 3, 2015Historical recordClass II

Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Published
December 3, 2014
Distribution
Kansas and Missouri

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FDA Recall TerminatedTerminated: June 16, 2015Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Published
December 3, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 26, 2016Historical recordClass III

Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16

by Zydus Pharmaceuticals USA Inc

Reason
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Published
December 3, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 3, 2016Historical recordClass II

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

by Baxter Healthcare Corp.

Reason
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Published
December 3, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 22, 2017Historical recordClass III

Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.

by Hospira Inc.

Reason
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Published
November 26, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 7, 2016Historical recordClass I

Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

by Abrams Royal Pharmacy

Reason
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Published
November 26, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 18, 2016Historical recordClass II

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

by Prometheus Laboratories Inc.

Reason
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Published
November 26, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 5, 2016Historical recordClass II

Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320

by Contract Packaging Resources Inc.

Reason
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Published
November 19, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 8, 2016Historical recordClass III

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

by Fresenius Kabi USA LLC

Reason
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Published
November 19, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 21, 2016Historical recordClass II

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

by Fougera Pharmaceuticals Inc.

Reason
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Published
November 19, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 30, 2016Historical recordClass III

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 30, 2016Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 30, 2016Historical recordClass III

Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
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.