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Recall totals

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

37,066

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 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 12, 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	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Ongoing Historical recordClass II

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35

by Akorn, Inc.

Reason: CGMP Deviations:
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05

by ACCORD HEALTHCARE, INC.

Reason: Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

ByHeart, INC.

Product: By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680…
Reason: Infant formula potentially contaminated with Cronobacter sakazakii
Published: January 25, 2023
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Something South African LLC

Product: Pepper Collection 8 Tube Gift Set - a colorful assortment of…
Reason: Due to presence of mold (Aspergillus brasiliensis) and Ochratoxin A.
Published: January 25, 2023
Distribution: Nationwide

View recall →

Data last updated: September 12, 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.