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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.

37,066
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,786
Class I recallsReasonable probability of serious health consequences
24,313
Class II recallsTemporary or medically reversible health consequences
2,876
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 II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 3,741–3,760 of 17,299 recalls

FDA Recall Completed Historical recordClass II

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

by AVKARE LLC

Reason
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Published
January 4, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01

by Hikma Pharmaceuticals USA Inc.

Reason
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Published
January 4, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Published
December 28, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Published
December 28, 2022
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

by Aurolife Pharma, LLC

Reason
Failed Impurities/Degradation Specifications
Published
December 28, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of foreign substance
Published
December 28, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26

by Camber Pharmaceuticals, Inc

Reason
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

by Atlantic Management Resources Ltd.

Reason
cGMP Deviations
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

by Exela Pharma Sciences LLC

Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.

by Exela Pharma Sciences LLC

Reason
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Published
December 21, 2022
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Published
December 14, 2022
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass II

Betty Buzz LLC

Product
Betty Buzz Sparkling Grapefruit - Non-alcoholic Beverage & M…
Reason
Beverage has off-odor
Published
December 14, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60

by Acella Pharmaceuticals, LLC

Reason
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Published
December 7, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed dissolution specifications
Published
December 7, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01

by Heritage Pharmaceuticals Inc

Reason
Subpotent Drug
Published
December 7, 2022
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Published
December 7, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

by Acella Pharmaceuticals, LLC

Reason
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Published
November 30, 2022
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.