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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

Newest recallhttps://www.fsis.usda.gov/recalls-alerts/fontanini-foods-llc-recalls-raw-frozen-pork-sausage-products-due-possible-foreignPublished September 25, 2026

Most affected stateHawaii 200 recalls mention this state

State: AS ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 27, 2026 ET

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

Recalls by class
Class	Recalls
Class II	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

FDA Recall Terminated Historical recordClass III

IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

by Akorn, Inc.

Reason: Subpotent Drug: Low out-of-specification potency result of the drug product.
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

by Hospira Inc.

Reason: Defective Container: There were customer complaints of cracked and leaking glass vials.
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5

by Apotex Inc.

Reason: Failed Stability Specifications: product may not meet specification limit for assay test.
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.

by EMD Serono, Inc.

Reason: Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix (37.5/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Published: September 23, 2015
Distribution: Nationwide

View recall →

Data last updated: September 27, 2026 ET

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.