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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: PR ×
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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 Terminated Historical recordClass III

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.

by SCA Pharmaceuticals

Reason: Subpotent Drug
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark

by DuPont Nutrition USA, Inc

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark

by DuPont Nutrition USA, Inc

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark

by DuPont Nutrition USA, Inc

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.

by Volt Candy Wholesale Club

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Published: March 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2;

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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FDA Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Published: March 8, 2023
Distribution: United States including Puerto Rico and…

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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.