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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 8, 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 United States Terminated Historical recordClass III

R&M TRADING LLC

Product: Instant Milk Tea Honeydew Flavor, R&M Refresher brand, B0D72…
Reason: The Instant Milk Tea Powder's ingredients statement declares Non-Dairy Creamer (Whey Powder, Sodium Caseinate) but does not specify milk.
Published: June 18, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5

by Consumer Product Partners, LLC

Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Published: June 11, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4

by Apotex Corp.

Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Published: June 11, 2025
Distribution: Nationwide

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FDA Recall Completed Historical recordClass II

Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)

by Torrent Pharma Inc.

Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Published: June 11, 2025
Distribution: Nationwide

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FDA Recall Completed Historical recordClass II

Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30

by Torrent Pharma Inc.

Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Published: June 11, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).

by Amerisource Health Services LLC

Reason: cGMP deviations
Published: June 11, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

Nordic Naturals, Inc.

Product: Nordic Naturals Zero Sugar Kids Multivitamin Supplement - Gu…
Reason: Product is mislabeled.
Published: June 11, 2025
Distribution: Domestic: AK, AZ, CA, CO, FL, GA, ID, IN…

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FDA Recall Ongoing Historical recordClass I

ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N

by EnShiShiXiangNiShangMaoYouXianGongSi

Reason: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

by Glenmark Pharmaceuticals Inc., USA

Reason: OOS results reported for the Dissolution (by UV) test.
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

by Alembic Pharmaceuticals Limited

Reason: Failed Impurities/Degradation Specifications
Published: June 4, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

by KVK Tech, Inc.

Reason: cGMP deviations
Published: May 28, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

by KVK Tech, Inc.

Reason: cGMP deviations
Published: May 28, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .

by AsttraZeneca Pharmaceuticals LP

Reason: Defective delivery system
Published: May 28, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Published: May 28, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Published: May 28, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

by CareFusion 213, LLC

Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Published: May 28, 2025
Distribution: Nationwide

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Data last updated: September 8, 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.