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Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.

Recall totals

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

37,115
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,793
Class I recallsReasonable probability of serious health consequences
24,343
Class II recallsTemporary or medically reversible health consequences
2,887
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/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 2026
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 II24,343
Class I9,793
Class III2,887
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1

Showing 6,461–6,480 of 18,020 recalls

FDA Recall Terminated Historical recordClass II

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Published
January 20, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

by KVK-Tech, Inc.

Reason
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Published
January 20, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

by US Compounding Inc

Reason
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Published
January 20, 2021
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

by Sunstar Americas, Inc.

Reason
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Published
January 20, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

by Akorn, Inc.

Reason
Defective container: Customer complaints for oral solution leaking from bottles.
Published
January 20, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
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.