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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
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 6,721–6,740 of 18,718 recalls

FDA Recall Terminated Historical recordClass II

Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012

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

labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028

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

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

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 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

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 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

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

Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809

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 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016

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/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122

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/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422

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

Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012

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 Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412

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 Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509

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

Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509

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

Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006

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

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054

by Ascend Laboratories LLC

Reason
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01

by Merck Sharp & Dohme

Reason
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Published
January 13, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9

by Wishgarden Herbs, Incorporated

Reason
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Published
January 6, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4

by Wishgarden Herbs, Incorporated

Reason
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Published
January 6, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5

by Wishgarden Herbs, Incorporated

Reason
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Published
January 6, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter - found in reserve sample vials at the firm.
Published
January 6, 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.