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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.

37,118
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,793
Class I recallsReasonable probability of serious health consequences
24,343
Class II recallsTemporary or medically reversible health consequences
2,887
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
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 II24,343
Class I9,793
Class III2,887
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1

Showing 9,341–9,360 of 17,327 recalls

FDA Recall Terminated Historical recordClass III

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

by Par Pharmaceutical, Inc.

Reason
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Published
September 19, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Published
September 19, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Published
September 12, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
September 12, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
September 12, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
September 12, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
September 12, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published
September 12, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

by MCKESSON CORPORATION

Reason
Supterpotent Drug
Published
September 12, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15

by Validus Pharmaceuticals, Inc.

Reason
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Published
September 5, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

by Validus Pharmaceuticals, Inc.

Reason
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0

by Pfizer Global Supply

Reason
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Published
September 5, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published
September 5, 2018
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.