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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).
  • 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 16,421–16,440 of 17,350 recalls

FDA Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

by Hospira Inc.

Reason
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0

by Apotex Corp.

Reason
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).

by Chang Kwung Products

Reason
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).

by Chang Kwung Products

Reason
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.

by Sandoz Incorporated

Reason
Presence of Particulate Matter: Found during examination of retention samples.
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07

by Baxter Healthcare Corp.

Reason
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30

by Torrent Pharma Inc

Reason
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA

by Actavis South Atlantic LLC

Reason
Failed Impurity/Degradation Specification; "Related Compound C"
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA

by Green Planet Inc

Reason
Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.

by Procter & Gamble Co

Reason
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07

by Warner Chilcott US LLC

Reason
Failed Impurities/Degradation Specifications: unspecified degradation product
Published
August 7, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724

by West-Ward Pharmaceutical Corp.

Reason
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.

by Watson Laboratories Inc

Reason
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.

by Astellas Pharma US Inc

Reason
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,

by Alkermes, Inc.

Reason
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

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

Reason
Failed Tablet/Capsule Specifications: Broken tablets
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM

by Max Huber Research Labs, Inc.

Reason
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM

by Max Huber Research Labs, Inc.

Reason
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Published
July 31, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM

by Max Huber Research Labs, Inc.

Reason
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Published
July 31, 2013
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.