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Recall totals

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

36,949

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,732

Class I recallsReasonable probability of serious health consequences

24,263

Class II recallsTemporary or medically reversible health consequences

2,873

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 2,071 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/foods-alive-recalls-organic-moringa-leaf-powder-because-possible-health-riskPublished September 4, 2026

Most affected stateHawaii 200 recalls mention this state

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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 6, 2026 ET

Summary (Year to date)

1,458 recalls have been announced year to date.
Aug 2026 was 53% 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	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

FDA Recall Ongoing 2026 recordClass II

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

by Ascend Laboratories, LLC

Reason: Failed Dissolution Specifications
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

by ENDO USA, Inc.

Reason: Crystallization; identified as Buprenorphine free base
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.

by Oasis Medical, Inc.

Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall United States Ongoing 2026 recordClass II

Dakota Honey Company

Product: Dakota Honey Company the Honey Flight. 4 Flavors of Spreada…
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall United States Ongoing 2026 recordClass II

Dakota Honey Company

Product: Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir…
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall United States Ongoing 2026 recordClass II

Dakota Honey Company

Product: Dakota Honey Company Spreadable Spun Honey, Salted Caramel.…
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall United States Ongoing 2026 recordClass II

Dakota Honey Company

Product: Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused…
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall United States Ongoing 2026 recordClass II

Dakota Honey Company

Product: Dakota Honey Company Spreadable Spun Honey, Original. Stir…
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Published: May 20, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass I

Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.

by B BRAUN MEDICAL INC

Reason: Presence of Particulate Matter.
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16

by Acella Pharmaceuticals, LLC

Reason: Chemical contamination; presence of lead and lithium above specification
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

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

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.

by Teva Pharmaceuticals USA, Inc

Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41

by CareFusion 213, LLC

Reason: Lack of assurance of Sterility: potential product contamination
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.

by CareFusion 213, LLC

Reason: Lack of assurance of Sterility: potential product contamination
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

by Ajanta Pharma Ltd.

Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

by Ajanta Pharma Ltd.

Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

by Ajanta Pharma Ltd.

Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

by Fresenius Medical Care Holdings, Inc.

Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Published: May 13, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

by Fresenius Medical Care Holdings, Inc.

Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Published: May 13, 2026
Distribution: Nationwide

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Data last updated: September 6, 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.