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Recall totals

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

37,113
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 6,021–6,040 of 18,020 recalls

FDA Recall Terminated Historical recordClass II

Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

by Spirit Pharmaceuticals

Reason
cGMP deviations: Discolored acetaminophen
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

by DuPont Nutrition USA, Inc

Reason
Out of specification results for conductivity.
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4

by High Performance Formulas, L.L.C. (HPF, L.L.C.)

Reason
Marketed Without an Approved NDA/ANDA
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19

by Novel Laboratories, Inc. d.b.a LUPIN

Reason
Failed Stability Specification; Out of specification for Osmolarity
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

by Noven Pharmaceuticals Inc

Reason
Failed Stability Specifications; out of specification for shear.
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

by Noven Pharmaceuticals Inc

Reason
Failed Stability Specifications; out of specification for shear.
Published
August 25, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Published
August 18, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Published
August 18, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Published
August 18, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05

by Aurobindo Pharma USA Inc.

Reason
Presence of Foreign Substance- Potential of metal contamination.
Published
August 18, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Published
August 18, 2021
Distribution
Texas and Puerto Rico

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.