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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 15,761–15,780 of 18,068 recalls

FDA Recall Terminated Historical recordClass I

Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA

by Central Admixture Pharmacy Services, Inc.

Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

by Hospira Inc.

Reason
Crystallization
Published
April 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

by Hospira Inc.

Reason
Crystallization
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.

by Heritage Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Published
April 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).

by Hospira Inc.

Reason
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Published
April 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84

by Navinta LLC

Reason
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Published
April 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.

by Qualitest Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Published
April 15, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)

by American Health Packaging

Reason
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Published
April 8, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

by Baxter Healthcare Corp

Reason
Lack of Assurance of Sterility; increased complaints received for leaks
Published
April 8, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04

by Baxter Healthcare Corp

Reason
Lack of Assurance of Sterility; increased complaints received for leaks
Published
April 8, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Published
April 1, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.

by Bethel Nutritional Consulting, Inc

Reason
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

by Mylan Institutional LLC

Reason
Lack of Assurance of Sterility; due to leaking vials
Published
April 1, 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.