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Recall totals

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

37,060

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/freshpoint-issues-recall-due-improperly-declared-allergen-egg-chicken-salad-wedge-sandwichesPublished September 8, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 9, 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

Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Published: November 6, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Published: November 6, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

by BLI International, Inc.

Reason: Superpotent Drug: Stability failure for assay at 6 months test time-point.
Published: November 6, 2024
Distribution: Product was shipped to two private label…

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Published: November 6, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Published: November 6, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Published: November 6, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.

by Akron Pharma, Inc.

Reason: CGMP Deviations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

by C & A Naturistics

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

by Fresenius Kabi Compounding, LLC

Reason: CGMP violations
Published: October 30, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80

by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Reason: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Published: October 23, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

by Bionpharma Inc.

Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Published: October 23, 2024
Distribution: Nationwide

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Data last updated: September 9, 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.