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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

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

State: GU ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 17, 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	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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 →

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 67751-152-01 67751-152-02

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 50269-222-25.

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

Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.

by Sanofi-Aventis U.S. LLC

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

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FDA Recall United States Terminated Historical recordClass I

Kettle Cuisine, LLC

Product: Marketside Creamy Cauliflower Parmesan Soup 16 ounce UPC C…
Reason: Soup labeled Creamy Cauliflower Parmesan Soup may contain undeclared fish and wheat
Published: December 11, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.

by Avantor Performance Materials Inc

Reason: Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Published: December 4, 2019
Distribution: Nationwide

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Data last updated: September 17, 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.