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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 September 2026.

37,061
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,786
Class I recallsReasonable probability of serious health consequences
24,313
Class II recallsTemporary or medically reversible health consequences
2,876
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
Newest recallhttps://www.fsis.usda.gov/recalls-alerts/el-eden-import-distributor-corp-recalls-ineligible-pork-cracklings-products-importedPublished September 9, 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)

  • 1,527 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 II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 1,441–1,460 of 18,725 recalls

FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Published
June 4, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

by Alembic Pharmaceuticals Limited

Reason
Failed Impurities/Degradation Specifications
Published
June 4, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

by KVK Tech, Inc.

Reason
cGMP deviations
Published
May 28, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

by KVK Tech, Inc.

Reason
cGMP deviations
Published
May 28, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .

by AsttraZeneca Pharmaceuticals LP

Reason
Defective delivery system
Published
May 28, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Published
May 28, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Published
May 28, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Published
May 28, 2025
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

View recall →

FDA Recall Terminated Historical recordClass II

Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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FDA Recall Terminated Historical recordClass II

Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

View recall →

FDA Recall Terminated Historical recordClass II

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.

by KENIL HEALTHCARE PRIVATE LIMITED

Reason
CGMP Deviations
Published
May 28, 2025
Distribution
DE and NC

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.