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Recall totals

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

37,341

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,860

Class I recallsReasonable probability of serious health consequences

24,450

Class II recallsTemporary or medically reversible health consequences

2,901

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 2,095 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/haifa-smoked-fish-recalls-cold-smoked-sprats-due-potential-health-riskPublished October 27, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated October 28, 2026 ET

Summary (Year to date)

1,739 recalls have been announced year to date.
Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (300).
Oct 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,450
Class I	9,860
Class III	2,901
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,450
Class I	9,860
Class III	2,901
Not Yet Classified	2

FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Maple Spice Best by date: 01/11/20-02/2…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Maple Pecan Best by date: 01/11/20-02/…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Coconut Ginger Best by date: 01/11/20-…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Coconut Crunch Best by date: 01/11/…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Original Best by date: 01/11/20-02/2…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Gluten Free Best by date: 01/11/20-02/…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Dark Chocolate Pecan Best by date: 01/1…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall United States TerminatedTerminated: March 13, 2020Historical recordClass II

Back Roads Food Company

Product: Back Roads Granola: Ancient Grains Best by date: 01/11/20-0…
Reason: Products may contain pieces of aluminum.
Published: May 22, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 20, 2023Historical recordClass I

Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044

by Par Pharmaceutical, Inc.

Reason: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Published: May 15, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: August 14, 2019Historical recordClass I

FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.

by Alvogen, Inc

Reason: Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Published: May 15, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: September 28, 2020Historical recordClass II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02

by Sagent Pharmaceuticals Inc

Reason: Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Published: May 15, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 29, 2021Historical recordClass II

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

by Zydus Pharmaceuticals USA Inc

Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Published: May 15, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: June 29, 2021Historical recordClass II

Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01

by Zydus Pharmaceuticals USA Inc

Reason: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Published: May 15, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: February 11, 2021Historical recordClass III

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.

by Advantice Health

Reason: Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Published: May 8, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: February 11, 2021Historical recordClass III

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6

by Advantice Health

Reason: Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Published: May 8, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: November 6, 2020Historical recordClass II

GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21

by American Health Packaging

Reason: Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Published: May 8, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: September 17, 2022Historical recordClass II

Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67

by US Worldmeds LLC

Reason: Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Published: May 8, 2019
Distribution: Nationwide

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FDA Recall TerminatedTerminated: February 16, 2021Historical recordClass II

BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019

by Pacifico National, Inc. dba AmEx Pharmacy

Reason: Defective Delivery System: difficult to express
Published: May 8, 2019
Distribution: Nationwide

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FDA Recall OngoingHistorical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

by Torrent Pharma Inc.

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Published: May 8, 2019
Distribution: Nationwide

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FDA Recall OngoingHistorical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

by Torrent Pharma Inc.

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Published: May 8, 2019
Distribution: Nationwide

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Data last updated: October 28, 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.