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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.

37,204
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,841
Class I recallsReasonable probability of serious health consequences
24,366
Class II recallsTemporary or medically reversible health consequences
2,892
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 2,073 recalls
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sierra-nevada-cheese-company-recalls-graziers-raw-milk-cheese-because-possible-health-riskPublished September 28, 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)

  • 1,714 recalls have been announced year to date.
  • Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (297).
Recalls by class

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2

Showing 15,561–15,580 of 18,578 recalls

FDA Recall Terminated Historical recordClass I

EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61.

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Published
September 2, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Published
September 2, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10

by UNICHEM PHARMACEUTICALS USA INC

Reason
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Published
September 2, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Published
September 2, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

by Bausch & Lomb, Inc.

Reason
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.

by Ucb, Inc

Reason
Failed Dissolution Testing: Failed 24 month dissolution testing.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86

by Sun Pharma Global Fze

Reason
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Published
August 26, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Published
August 26, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.

by GC Natural Nutrition, Inc.

Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Published
August 26, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Published
August 19, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Published
August 19, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

by Fresenius Kabi USA, LLC

Reason
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Published
August 19, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
August 19, 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.