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Recall totals

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

36,950

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/made-fresh-salads-inc-recalls-ready-eat-deli-style-salads-and-cream-cheese-because-possible-healthPublished September 6, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 7, 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 Historical recordClass II

Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Published: November 26, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

by Golden State Medical Supply Inc.

Reason: Failed Dissolution Specifications
Published: November 26, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05

by Imprimis NJOF, LLC

Reason: Subpotent Drug
Published: November 26, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

by Alembic Pharmaceuticals Limited

Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Published: November 26, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Plenus Group Inc.

Product: Rockport Lobser Bisque; packed in 2x8lb pouches and in 4x4b…
Reason: Products contain undeclared shrimp (crustacean shellfish)
Published: November 26, 2025
Distribution: Massachusetts, Michigan, New Hampshire,…

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FDA Recall United States Terminated Historical recordClass I

Lotus Vaping Technologies, LLC

Product: Monarch Premium Kratom White Elephant powder is packaged in…
Reason: Product has the potential to be contaminated with Salmonella
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Lotus Vaping Technologies, LLC

Product: Monarch Premium Kratom Red Bali powder is packaged in seal m…
Reason: Product has the potential to be contaminated with Salmonella
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Lotus Vaping Technologies, LLC

Product: Monarch Premium Kratom Green Maeng Da powder is packaged in…
Reason: Product has the potential to be contaminated with Salmonella
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Lotus Vaping Technologies, LLC

Product: Monarch Premium Kratom Bali Gold powder is packaged in seal…
Reason: Product has the potential to be contaminated with Salmonella
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Professional Botanicals, Inc.

Product: Product Name: Tense-X. Package: 175cc HDPE Bottle. Type: Veg…
Reason: Products contains Magnesium Salicylate.
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Professional Botanicals, Inc.

Product: Product Name: Total Comfort. Package: 175cc HDPE Bottle. Typ…
Reason: Products contains Magnesium Salicylate.
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Professional Botanicals, Inc.

Product: Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: V…
Reason: Products contains Magnesium Salicylate.
Published: November 19, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01

by Aero Healthcare

Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass II

Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

Product: Publix Large Shrimp Peeled & Deveined Tail On 31/40, net wt.…
Reason: Shrimp may be contaminated with Cesium-137 (Cs-137).
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass II

Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

Product: Publix Extra Large Shrimp Easy to Peel Deveined 21/25, net w…
Reason: Shrimp may be contaminated with Cesium-137 (Cs-137).
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass II

Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

Product: AquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs.…
Reason: Shrimp may be contaminated with Cesium-137 (Cs-137).
Published: November 12, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass II

Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

Product: AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lb…
Reason: Shrimp may be contaminated with Cesium-137 (Cs-137).
Published: November 12, 2025
Distribution: Nationwide

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Data last updated: September 7, 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.