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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.

37,062
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,786
Class I recallsReasonable probability of serious health consequences
24,313
Class II recallsTemporary or medically reversible health consequences
2,876
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/evergreen-fresh-sprouts-llc-recalls-broccoli-sprouts-because-possible-health-riskPublished September 10, 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 II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 2,341–2,360 of 18,528 recalls

FDA Recall Completed Historical recordClass II

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

by Eli Lilly & Company

Reason
CGMP Deviations
Published
April 24, 2024
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10

by Novitium Pharma LLC

Reason
Failed Impurities/Degradation Specifications
Published
April 24, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

by Amneal Pharmaceuticals of New York, LLC

Reason
Superpotent Drug: Due to overfilling of drug powder
Published
April 24, 2024
Distribution
Nationwide

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FDA Recall Completed Historical recordClass III

NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03

by Esperion

Reason
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Published
April 24, 2024
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03

by Specialty Process Labs LLC

Reason
Failed Stability Specifications
Published
April 24, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.

by AvKARE

Reason
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Published
April 24, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

by Eugia US LLC

Reason
Presence of Particulate Matter
Published
April 17, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

by Teva Pharmaceuticals USA, Inc

Reason
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Published
April 17, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41

by NATCO Pharma Limited

Reason
CGMP Deviations
Published
April 17, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug
Published
April 17, 2024
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass I

Backstage Center DBA CTC Seller

Product
Alipotec Raiz de Tejocote dietary supplements, Net. Wt. 0.35…
Reason
The "Alipotec King" Alipotec Raiz de Tejocote product was found to contain toxic yellow oleander instead of tejocote.
Published
April 17, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.

by X-Gen Pharmaceuticals Inc.

Reason
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Published
April 10, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.

by X-Gen Pharmaceuticals Inc.

Reason
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Published
April 10, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1

by IntegraDose Compounding Services LLC

Reason
Lack of Assurance of Sterility: leaking bags
Published
April 10, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

by B. Braun Medical Inc

Reason
Lack of assurance of sterility: bags have the potential to leak..
Published
April 10, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Published
April 10, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01

by Par Sterile Products LLC

Reason
Presence of Particulate Matter.
Published
April 3, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62

by Teva Pharmaceuticals USA, Inc

Reason
Failed Dissolution Specifications
Published
April 3, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01

by Apothecus Pharmaceutical Corp.

Reason
cGMP Diviations
Published
April 3, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed dissolution specifications
Published
April 3, 2024
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.