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Recall totals

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

37,061
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
Most affected stateHawaii 200 recalls mention this state

Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

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

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 2,201–2,220 of 17,299 recalls

FDA Recall Terminated Historical recordClass II

labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall United States Terminated Historical recordClass II

WS Global Inc

Product
Himalayan Pain Relief Tea for Gout and Hangover
Reason
Contains undeclared drugs Diclofenac and Dexamethasone Acetate
Published
April 3, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

by Super Chill Products

Reason
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Published
March 27, 2024
Distribution
Nationwide

View recall →

Data last updated:

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.