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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
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 15,721–15,740 of 17,350 recalls

FDA Recall Terminated Historical recordClass II

Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

by Apothecure, Inc

Reason
Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.

by Forest Pharmaceuticals Inc

Reason
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.

by Forest Pharmaceuticals Inc

Reason
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33

by Forest Pharmaceuticals Inc

Reason
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56

by Teva Pharmaceuticals USA, Inc.

Reason
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)

by Actavis Inc

Reason
Failed Tablet/Capsule Specifications: Broken tablets
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

by Greenstone Llc

Reason
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66

by Pfizer Inc.

Reason
Failed Dissolution Specification; 8 hr stability timepoint
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.

by Insight Instruments, Inc.

Reason
Marketed without an Approved NDA/ANDA.
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Published
February 12, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244

by NuVision Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Published
February 5, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

by NuVision Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Published
February 5, 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.