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Recall totals

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

37,324
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,859
Class I recallsReasonable probability of serious health consequences
24,440
Class II recallsTemporary or medically reversible health consequences
2,900
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 2,095 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 II24,440
Class I9,859
Class III2,900
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,440
Class I9,859
Class III2,900
Not Yet Classified2

Showing 4,221–4,240 of 19,481 recalls

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason
cGMP deviations
Published
April 5, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: November 8, 2024Historical recordClass II

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.

by Endo Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: July 17, 2023Historical recordClass II

Rieckhoff Family Businesses, Inc.

Product
Almost Famous Popcorn Poppy Chow, 9.9 oz bag (UPC 8 50011515…
Reason
Peanuts are declared in the ingredients statement, but they are not declared in the allergen contains statement.
Published
April 5, 2023
Distribution
Retail stores in CO, IA, IL, KS, MN, MO,…

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FDA Recall United States TerminatedTerminated: May 2, 2023Historical recordClass I

THE ISH COMPANY

Product
ISH Shrimpish Sample Meal Kit: ( Sample Meal Kit ) a package…
Reason
undeclared soy proteins
Published
April 5, 2023
Distribution
Multiple states

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FDA Recall United States TerminatedTerminated: January 15, 2025Historical recordClass II

BINDLE BOTTLE

Product
Stainless Steel Water Bottle The product comes in four sizes…
Reason
Water bottle has a cup with a screw cap attached by a weld that has been found to leach lead.
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass I

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

by Global Pharma Healthcare Private Limited

Reason
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Published
March 29, 2023
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 18, 2023Historical recordClass III

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Content Uniformity Specifications
Published
March 29, 2023
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for shear.
Published
March 29, 2023
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for shear.
Published
March 29, 2023
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for shear.
Published
March 29, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for shear.
Published
March 29, 2023
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.

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