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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.

36,949
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/foods-alive-recalls-organic-moringa-leaf-powder-because-possible-health-riskPublished September 4, 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 21–40 of 19,117 recalls

FDA Recall Ongoing 2026 recordClass II

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34

by Novartis Pharmaceuticals Corporation

Reason
Failed Dissolution Specifications
Published
August 19, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Published
August 12, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass I

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

by Sunny Pharmtech Inc.

Reason
Presence of Particulate Matter; identified as stainless steel
Published
August 12, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass I

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

by Sunny Pharmtech Inc.

Reason
Presence of Particulate Matter; identified as stainless steel
Published
August 12, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99

by Aurobindo Pharma USA Inc

Reason
shortfill; reports of empty capsules.
Published
August 12, 2026
Distribution
Nationwide

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FDA Recall United States Ongoing 2026 recordClass I

AKKARCO LLC

Product
Ashfiat Alharamain Energy Support 250ml/8fl. oz.
Reason
Undeclared tadalafil
Published
August 12, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass III

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

by Ascend Laboratories, LLC

Reason
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.

by MYLAN PHARMACEUTICALS INC

Reason
Presence of precipitate
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.

by MICRO LABS USA INC

Reason
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall United States Ongoing 2026 recordClass II

Mellish Island Corp

Product
Mellish Island Super Skin; Dietary Supplement; 60 Capsules,…
Reason
Firm's finished product label does not declare the source of marine collagen which was determined to be fish.
Published
August 5, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass III

Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.

by Supernus Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications
Published
July 29, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

by Bionpharma Inc.

Reason
Presence of Foreign Tablets/Capsules
Published
July 29, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

by Precision Dose Inc.

Reason
Failed Impurities/Degradation Specifications
Published
July 29, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Published
July 29, 2026
Distribution
Nationwide

View recall →

FDA Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Published
July 29, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass I

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Published
July 29, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter: Hair was found in products
Published
July 29, 2026
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.