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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.

37,063
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
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 2,561–2,580 of 17,299 recalls

FDA Recall Ongoing Historical recordClass II

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications
Published
November 15, 2023
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass III

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

by Zyla Life Sciences US Inc.

Reason
Sub-potent Drug: Lower potency than labeled.
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.

by VistaPharm LLC

Reason
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications: Out of specification for dissolution.
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79

by MEDLINE INDUSTRIES, LP - Northfield

Reason
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed Dissolution Specifications
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1

by Taro Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

by Par Sterile Products LLC

Reason
Crystallization; identified as Buprenorphine free base
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

by Dr. Reddy's Laboratories, Inc.

Reason
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass III

The Sausage Maker, Inc.

Product
The Sausage Maker Instacure #1
Reason
Contains Sodium Nitrite recalled for potential metal contamination
Published
November 15, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Impurities/Degradation Specifications
Published
November 8, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurities/Degradation Specifications.
Published
November 8, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurities/Degradation Specifications.
Published
November 8, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15

by Safecor Health, LLC

Reason
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Published
November 8, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

by Padagis US LLC

Reason
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Published
November 8, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01

by Edenbridge Pharmaceuticals, LLC

Reason
Subpotent Drug
Published
November 8, 2023
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Published
November 8, 2023
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Published
November 8, 2023
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Published
November 8, 2023
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Published
November 8, 2023
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.