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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.

37,142
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 15,421–15,440 of 17,335 recalls

FDA Recall Terminated Historical recordClass II

Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026

by Dermamedics, L.L.C.

Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

by Boehringer Ingelheim Roxane Inc

Reason
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC

by Mckesson Packaging Services

Reason
Failed Dissolution Specification; at the 12 month time interval.
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France

by Estee Lauder Inc

Reason
Stability Data Does Not Support Expiry
Published
July 30, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Published
July 30, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.

by X-Gen Pharmaceuticals Inc.

Reason
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Published
July 30, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70

by Pfizer Inc.

Reason
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.

by Fougera Pharmaceuticals Inc.

Reason
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

by Fougera Pharmaceuticals Inc.

Reason
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA

by Axcentria Pharmaceuticals, LLC

Reason
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.

by Poly Pharmaceuticals, Inc

Reason
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.

by Poly Pharmaceuticals, Inc

Reason
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Published
July 23, 2014
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.