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Recall totals

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

37,142
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,799
Class I recallsReasonable probability of serious health consequences
24,349
Class II recallsTemporary or medically reversible health consequences
2,891
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 II24,349
Class I9,799
Class III2,891
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,349
Class I9,799
Class III2,891
Not Yet Classified1

Showing 14,441–14,460 of 17,335 recalls

FDA Recall Terminated Historical recordClass III

Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.

by AstraZeneca Pharmaceuticals LP

Reason
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11

by American Health Packaging

Reason
Failed dissolution specifications
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.

by West-Ward Pharmaceutical Corp.

Reason
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.

by Allegiant Health

Reason
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

by Baxter Healthcare Corp

Reason
Subpotent Drug; out of specification results for heparin raw material
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06

by Sandoz, Inc

Reason
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.

by Fresenius Kabi USA, LLC

Reason
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433

by Medtech Products, Inc.

Reason
Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: OOS result during stability testing
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

by Mylan Lab Inc

Reason
Failed Dissolution Specifications: Low out of specification dissolution results.
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

by Hospira Inc.

Reason
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Published
June 3, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Published
June 3, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Published
June 3, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Published
June 3, 2015
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.