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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.

36,950
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,732
Class I recallsReasonable probability of serious health consequences
24,263
Class II recallsTemporary or medically reversible health consequences
2,873
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 2,071 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)

  • 1,458 recalls have been announced year to date.
  • Aug 2026 was 53% 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 II24,263
Class I9,732
Class III2,873
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,263
Class I9,732
Class III2,873
Not Yet Classified1

Showing 1,001–1,020 of 18,483 recalls

FDA Recall Ongoing Historical recordClass II

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28

by AvKARE

Reason
Failed Content Uniformity Specifications
Published
October 15, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

by ACCORD HEALTHCARE, INC.

Reason
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Published
October 15, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.

by Acuity Specialty Products, Inc.

Reason
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Published
October 15, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.

by Acuity Specialty Products, Inc.

Reason
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Published
October 15, 2025
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

by RC Outsourcing, LLC

Reason
Lack of assurance of sterility.
Published
October 15, 2025
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass II

M.O.M Enterprises, LLC.

Product
Organic BABY bedtime drops; sleep + immunity blend; Promotes…
Reason
Potential yeast contamination.
Published
October 15, 2025
Distribution
Multiple states

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FDA Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

by Apotex Corp.

Reason
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Published
October 8, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).

by Apotex Corp.

Reason
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Published
October 8, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

by Amerisource Health Services LLC

Reason
Failed Dissolution Specifications.
Published
October 8, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Published
October 8, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Published
October 8, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass III

READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25

by Medline Industries, LP

Reason
Subpotent drug
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01

by Granules Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications:
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

by Granules Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications:
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01

by Granules Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications:
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01

by Granules Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications:
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01

by Granules Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications:
Published
October 1, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Market complaints received for gritty texture (grainy)
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14

by Consumer Product Partners, LLC

Reason
Cross Contamination with Other Products.
Published
October 1, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14

by Consumer Product Partners, LLC

Reason
Cross Contamination with Other Products.
Published
October 1, 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.