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Recall totals

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

37,115

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,793

Class I recallsReasonable probability of serious health consequences

24,343

Class II recallsTemporary or medically reversible health consequences

2,887

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 recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 17, 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	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

FDA Recall Terminated Historical recordClass II

fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX

by Johnson Matthey Inc.

Reason: cGMP Deviations: Potential glass contamination
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001

by Johnson Matthey Inc.

Reason: cGMP Deviations: Potential glass contamination
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.

by Johnson Matthey Inc.

Reason: cGMP Deviations: Potential glass contamination
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30

by Akorn, Inc.

Reason: cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.

by Cardinal Health dba Specialty Pharmaceutical Services

Reason: Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707

by Darmerica, LLC

Reason: Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24

by Pfizer Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Published: October 2, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2

by Pfizer Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Published: October 2, 2019
Distribution: Nationwide

View recall →

Data last updated: September 17, 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.