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Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.

37,115
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 6,861–6,880 of 17,833 recalls

FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Published
April 29, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

by B & B Pharmaceuticals, Inc.

Reason
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

by Filltech USA, LLC

Reason
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698

by Filltech USA, LLC

Reason
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA

by Golden State Medical Supply Inc.

Reason
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass I

Mountain Rose Inc. dba Mountain Rose Herbs

Product
Kudzu Root (Pueraria montana var. lobata), This product was…
Reason
Salmonella
Published
April 22, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

by Avet Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Published
April 15, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

by Avet Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Published
April 15, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816

by Avet Pharmaceuticals, Inc.

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Published
April 15, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09

by Avet Pharmaceuticals, Inc.

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Published
April 15, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Published
April 15, 2020
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.