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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 7,121–7,140 of 17,327 recalls

FDA Recall Ongoing Historical recordClass II

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120. NDC: 51552-1539-1

by Fagron, Inc

Reason
Microbial contamination of non-sterile product.
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,

by Pacira Pharmaceuticals, Inc.

Reason
Sub Potent Drug: Out of Specification (OOS)
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
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.