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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 4,101–4,120 of 17,299 recalls

FDA Recall Terminated Historical recordClass II

FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.

by Strides Pharma Inc.

Reason
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

by AVKARE Inc.

Reason
Labeling: Label Error on Declared Strength
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

by CIPLA

Reason
Lack of Assurance of Sterility: Complaints received of defective container closure.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Published
August 17, 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.