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Recall totals

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

37,066

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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 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 12, 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

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Ongoing Historical recordClass II

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

by Ascend Laboratories, LLC

Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

by Ascend Laboratories, LLC

Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

by Direct Rx

Reason: cGMP deviations
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.

by Endo Pharmaceuticals, Inc.

Reason: Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

BINDLE BOTTLE

Product: Stainless Steel Water Bottle The product comes in four sizes…
Reason: Water bottle has a cup with a screw cap attached by a weld that has been found to leach lead.
Published: April 5, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

by Global Pharma Healthcare Private Limited

Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Published: March 29, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Content Uniformity Specifications
Published: March 29, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Published: March 29, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Published: March 29, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3

by Noven Pharmaceuticals Inc

Reason: Defective Delivery System: Out of specification for shear.
Published: March 29, 2023
Distribution: Nationwide

View recall →

Data last updated: September 12, 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.