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Recall totals

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

37,449

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,872

Class I recallsReasonable probability of serious health consequences

24,509

Class II recallsTemporary or medically reversible health consequences

2,932

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 2,096 recalls

Newest recallhttps://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-meat-and-poultry-products-due-misbranding-andPublished November 6, 2026

Most affected stateHawaii 200 recalls mention this state

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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated November 8, 2026 ET

Summary (Year to date)

1,956 recalls have been announced year to date.
Oct 2026 was 4% higher than the previous complete period (Sep 2026: 209).
The highest complete period was Jun 2026 (300).
Nov 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,509
Class I	9,872
Class III	2,932
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,509
Class I	9,872
Class III	2,932
Not Yet Classified	2

FDA Recall TerminatedTerminated: February 19, 2021Historical recordClass II

Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01

by Alkermes, Inc.

Reason: Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677124

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199

by KRS Global Biotechnology, Inc

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

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FDA Recall TerminatedTerminated: August 19, 2021Historical recordClass II

Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092

by KRS Global Biotechnology, Inc

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

View recall →

Data last updated: November 8, 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.