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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: GU ×
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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

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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 Ongoing Historical recordClass II

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

by Denison Pharmaceuticals, LLC

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02

by Denison Pharmaceuticals, LLC

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.

by Revive Rx LLC dba Revive Rx Pharmacy

Reason: Sub-potent Drug
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Completed Historical recordClass II

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

by Aurobindo Pharma USA Inc.

Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

by Sagent Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10

by Sagent Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

by Sagent Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications; during stability testing
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: May 31, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: May 31, 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.