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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 13,901–13,920 of 18,028 recalls

FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Published
June 1, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com

by Lipo Escultura Corp.

Reason
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Published
June 1, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Published
June 1, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30

by Lymol Medical

Reason
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Published
June 1, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.

by Pfizer Inc.

Reason
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Published
June 1, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

by Allegiant Health

Reason
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Published
May 25, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03

by TMIG Inc

Reason
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Published
May 25, 2016
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

by Hospira Inc.

Reason
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Published
May 25, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87

by Baxter Healthcare Corp.

Reason
Discoloration: presence of atypical yellow discoloration of the solution .
Published
May 18, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications; 12 month stability time point
Published
May 18, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

by Mylan Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications; three month stability time point.
Published
May 18, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

by VistaPharm, Inc.

Reason
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Published
May 11, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.

by Bryant Ranch Prepack Inc.

Reason
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Published
May 11, 2016
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass III

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

by Hospira Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Published
May 11, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.

by Akorn, Inc.

Reason
Presence of Particulate Matter
Published
May 11, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.

by Mckesson Packaging Services

Reason
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Published
May 4, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.

by AbbVie Inc.

Reason
Failed Content Uniformity Specifications
Published
April 27, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Published
April 27, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Published
April 27, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Published
April 27, 2016
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.