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Recall totals

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

37,116
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 8,881–8,900 of 17,327 recalls

FDA Recall Terminated Historical recordClass II

Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.

by Dr. Reddy's Laboratories, Inc.

Reason
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.

by Tris Pharma Inc.

Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.

by Tris Pharma Inc.

Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.

by Tris Pharma Inc.

Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10

by Akorn Inc

Reason
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.

by US Compounding Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 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.