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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.

37,059
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 recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/made-fresh-salads-inc-recalls-ready-eat-deli-style-salads-and-cream-cheese-because-possible-healthPublished September 6, 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 1,141–1,160 of 17,993 recalls

FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Published
August 20, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10

by Westminster Pharmaceuticals LLC

Reason
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications: low dissolution results
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 1…
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC:…
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UP…
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC…
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Terminated Historical recordClass III

Enjoy Nutrition, LLC; dba Weyland Brain Nutrition

Product
Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC.…
Reason
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Terminated Historical recordClass III

Enjoy Nutrition, LLC; dba Weyland Brain Nutrition

Product
Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC.…
Reason
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Terminated Historical recordClass III

Enjoy Nutrition, LLC; dba Weyland Brain Nutrition

Product
Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. U…
Reason
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 1…
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-820…
Reason
Product label includes the ingredient CREAM but does not include Milk as the source.
Published
August 20, 2025
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.