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Recall totals

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

37,205
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
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).
  • Oct 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 II24,366
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 16,161–16,180 of 18,068 recalls

FDA Recall Terminated Historical recordClass II

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.

by Fougera Pharmaceuticals Inc.

Reason
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

by Fougera Pharmaceuticals Inc.

Reason
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA

by Axcentria Pharmaceuticals, LLC

Reason
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.

by Poly Pharmaceuticals, Inc

Reason
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.

by Poly Pharmaceuticals, Inc

Reason
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Published
July 23, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10

by Fresenius Kabi USA, LLC

Reason
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02

by Fresenius Kabi USA, LLC

Reason
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

by Boehringer Ingelheim Roxane Inc

Reason
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

by Ferring Pharmaceuticals Inc

Reason
Discoloration; due to prolonged heat exposure.
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

by Hospira Inc.

Reason
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Published
July 16, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Published
July 9, 2014
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.