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Recall totals

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

37,205
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,841
Class I recallsReasonable probability of serious health consequences
24,366
Class II recallsTemporary or medically reversible health consequences
2,892
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 2,073 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)

  • 1,714 recalls have been announced year to date.
  • Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (297).
  • Oct 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 II24,366
Class I9,841
Class III2,892
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2

Showing 15,801–15,820 of 18,068 recalls

FDA Recall Terminated Historical recordClass II

Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05

by Sagent Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

by Qualitest Pharmaceuticals

Reason
Failed tablet specifications: One lot was found to contain oversized tablets.
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15

by Actavis Inc

Reason
Subpotent Drug
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.

by Actavis Elizabeth LLC

Reason
Failed Dissolution Specifications
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.

by Sun Pharma Global Fze

Reason
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Published
March 4, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)

by Par Pharmaceutical Inc.

Reason
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Published
March 4, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09

by Hospira Inc.

Reason
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Published
February 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Published
February 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Published
February 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Published
February 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Published
February 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Published
February 25, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86

by Sun Pharma Global Fze

Reason
Failed Dissolution Specifications: 6 month time point.
Published
February 18, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .

by Akorn, Inc.

Reason
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Published
February 18, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.

by AnazaoHealth Corporation

Reason
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Published
February 18, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Published
February 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

by Hospira Inc.

Reason
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Published
February 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

by Hospira Inc.

Reason
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Published
February 4, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Published
February 4, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.

by Valeant Pharmaceuticals North America LLC

Reason
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Published
January 28, 2015
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.