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Recall totals

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

37,326

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,859

Class I recallsReasonable probability of serious health consequences

24,440

Class II recallsTemporary or medically reversible health consequences

2,900

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 2,095 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/winco-foods-llc-issues-allergy-alert-undeclared-sesame-hoagie-rollsPublished October 22, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated October 23, 2026 ET

Summary (Year to date)

1,739 recalls have been announced year to date.
Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (300).
Oct 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,440
Class I	9,859
Class III	2,900
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,440
Class I	9,859
Class III	2,900
Not Yet Classified	2

FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility.
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 7, 2023Historical recordClass II

ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: May 31, 2023Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.

by Ascend Laboratories, LLC

Reason: Failed Dissolution Specifications.
Published: February 2, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 21, 2023Historical recordClass II

Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.

by Medique Products

Reason: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Published: January 26, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: December 13, 2024Historical recordClass II

Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04

by VistaPharm, Inc.

Reason: Failed Stability Specifications
Published: January 26, 2022
Distribution: Nationwide

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FDA Recall TerminatedTerminated: January 12, 2024Historical recordClass I

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

by MYLAN PHARMACEUTICALS INC

Reason: Labeling: Missing Label: label missing from some Semglee prefilled pens.
Published: January 26, 2022
Distribution: Nationwide

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Data last updated: October 23, 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.