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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.

37,271
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,852
Class I recallsReasonable probability of serious health consequences
24,397
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 2,085 recalls
Newest recallhttps://www.fsis.usda.gov/recalls-alerts/kayem-foods-inc--recalls-meat-and-poultry-products-due-possible-temperature-abusePublished October 17, 2026
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 II24,397
Class I9,852
Class III2,897
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,397
Class I9,852
Class III2,897
Not Yet Classified2

Showing 3,481–3,500 of 17,412 recalls

FDA Recall TerminatedTerminated: October 19, 2023Historical recordClass II

Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03

by RemedyRePack Inc.

Reason
cGMP Deviations
Published
April 12, 2023
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: December 4, 2023Historical recordClass II

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

by Azurity Pharmaceuticals, Inc.

Reason
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Published
April 12, 2023
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: March 21, 2025Historical recordClass I

Perrigo Nutritionals

Product
Gerber GoodStart SoothePro Infant Formula with Iron. Milk…
Reason
Infant Formula has the potential to be contaminated with Cronobacter spp.
Published
April 12, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

by Ascend Laboratories, LLC

Reason
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

by Ascend Laboratories, LLC

Reason
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Published
April 5, 2023
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 17, 2024Historical recordClass II

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, 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, 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

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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

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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

View recall →

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

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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: 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

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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