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Recall totals

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

37,060

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/freshpoint-issues-recall-due-improperly-declared-allergen-egg-chicken-salad-wedge-sandwichesPublished September 8, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 9, 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

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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

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

by Granules Pharmaceuticals Inc.

Reason: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

by Eugia US LLC

Reason: Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India

by Eugia US LLC

Reason: CGMP Deviations
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21

by Amerisource Health Services LLC

Reason: Presence of Foreign Tablets/Capsules
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

by West-Ward Columbus Inc

Reason: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

by FDC Limited

Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).

by ENDO USA, Inc.

Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).

by ENDO USA, Inc.

Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).

by ENDO USA, Inc.

Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).

by ENDO USA, Inc.

Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.

by Buy-Herbal

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Published: January 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

by AvKARE

Reason: LABELING: LABEL MIX-UP
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.

by AvKARE

Reason: LABELING: LABEL MIX-UP
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

by Hikma Injectables USA Inc

Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

by Hikma Injectables USA Inc

Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

by GNMart LLC

Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Published: January 8, 2025
Distribution: Nationwide

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Data last updated: September 9, 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.