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Recall totals

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

37,142
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,799
Class I recallsReasonable probability of serious health consequences
24,349
Class II recallsTemporary or medically reversible health consequences
2,891
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 II24,349
Class I9,799
Class III2,891
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,349
Class I9,799
Class III2,891
Not Yet Classified1

Showing 15,061–15,080 of 17,335 recalls

FDA Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Published
March 18, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15

by Actavis Inc

Reason
Subpotent Drug
Published
March 11, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.

by Akorn, Inc.

Reason
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications
Published
March 11, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15

by AVKARE Inc.

Reason
Subpotent Drug
Published
March 11, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15

by AVKARE Inc.

Reason
Subpotent Drug
Published
March 11, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10

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

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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 →

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.