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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

Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749

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

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401

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

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861

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

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039

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

PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379

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

PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170

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

Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441

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

OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819

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

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

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

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406

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

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032

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

Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103

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

NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303

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

NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847

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

Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320

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

Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126

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

Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355

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

Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232

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

Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952

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

LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 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.