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Recall totals

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

37,206
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 16,941–16,960 of 18,578 recalls

FDA Recall Terminated Historical recordClass III

VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.

by Bracco Diagnostics Inc

Reason
Failed Stability Testing: This product is below specification for preservative content.
Published
February 19, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

by Watson Laboratories, Inc.-(Actavis) - Florida

Reason
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Published
February 19, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI....

by Caraco Pharmaceutical Laboratories Ltd.

Reason
Failed Tablet Specifications: Broken Tablets Present.
Published
February 19, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10

by Corepharma LLC

Reason
Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072

by Faria Limited LLC dba Sheffield Pharmaceuticals

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105

by Faria Limited LLC dba Sheffield Pharmaceuticals

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320

by Faria Limited LLC dba Sheffield Pharmaceuticals

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Published
February 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (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

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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

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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

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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

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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 →

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.