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Recall totals

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

37,063
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 2,121–2,140 of 17,202 recalls

FDA Recall Terminated Historical recordClass II

EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01

by Regeneron Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: Complaints of syringe breakage
Published
May 8, 2024
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass III

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

by Imprimis NJOF, LLC

Reason
Out of specification for assay
Published
May 8, 2024
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed Dissolution Specifications
Published
May 8, 2024
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

by Imprimis NJOF, LLC

Reason
Subpotent Drug
Published
May 8, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.

by EPI Health, LLC

Reason
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.

by EPI Health, LLC

Reason
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90

by EPI Health, LLC

Reason
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53

by Cipla USA, Inc.

Reason
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

by FA Online Inc

Reason
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Published
May 1, 2024
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason
Cross Contamination with Other Products
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Published
May 1, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Published
May 1, 2024
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Published
May 1, 2024
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.

by Nomax Inc

Reason
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Published
May 1, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37

by HONEYWELL INC

Reason
CGMP Deviations
Published
May 1, 2024
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass I

Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5

by Aruba Aloe Balm N.V.

Reason
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Published
May 1, 2024
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.