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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 Terminated Historical recordClass III

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

by SOMERSET THERAPEUTICS LLC

Reason: Failed Impurities/Degradation Specifications
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.

by AvKARE

Reason: Failed Dissolution Specifications
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

BALOIAN FARMS

Product: whole fresh American cucumbers packaged in bulk cardboard co…
Reason: Cucumbers potentially contaminated with Salmonella.
Published: January 8, 2025
Distribution: Distributed to the following states: AK,…

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FDA Recall United States Terminated Historical recordClass II

Sam'S Club

Product: Member's Mark Hatch Chile Chicken Enchiladas, ready to cook,…
Reason: Presence of Listeria monocytogenes
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

by RemedyRePack Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40

by Curium US, LLC

Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

by Macleods Pharmaceuticals Ltd

Reason: Failed Impurities/Degradation Specifications
Published: December 25, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01

by Regenerative Processing Plant, LLC

Reason: Lack of Sterility Assurance
Published: December 25, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01

by Regenerative Processing Plant, LLC

Reason: Lack of Sterility Assurance
Published: December 25, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

by Apothecus Pharmaceutical Corp.

Reason: CGMP deviations: out of specifications for assay
Published: December 25, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

by Provepharm Inc.

Reason: Discoloration
Published: December 25, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

by Aurobindo Pharma USA Inc

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Published: December 25, 2024
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.