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Recall totals

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

37,271
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,852
Class I recallsReasonable probability of serious health consequences
24,397
Class II recallsTemporary or medically reversible health consequences
2,897
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 2,085 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)

  • 1,739 recalls have been announced year to date.
  • Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (300).
  • 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 II24,397
Class I9,852
Class III2,897
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,397
Class I9,852
Class III2,897
Not Yet Classified2

Showing 2,181–2,200 of 17,287 recalls

FDA Recall OngoingHistorical recordClass III

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
May 29, 2024
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: November 27, 2024Historical recordClass III

Natural Waters of Viti Limited

Product
Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code:…
Reason
Firm testing revealed Manganese in addition to three bacterial genera.
Published
May 29, 2024
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: November 7, 2024Historical recordClass II

Colonna Brothers Inc.

Product
Supreme Tradition brand and Marcum brand ground cinnamon. Pa…
Reason
Elevated lead levels in cinnamon
Published
May 29, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9

by Pharma Nobis LLC

Reason
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

by Pharma Nobis LLC

Reason
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

by Sagent Pharmaceuticals

Reason
Presence of Particulate Matter: Potential for black particulates in the drug product.
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

by MACLEODS PHARMA USA, INC

Reason
Presence of foreign substance: plastic-like substance.
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04

by Lupin Pharmaceuticals Inc.

Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 29, 2025Historical recordClass II

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

by Lupin Pharmaceuticals Inc.

Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall CompletedHistorical recordClass II

Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01

by Dercher Enterprises, Inc., DBA Gordon Laboratories

Reason
cGMP Deviations
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: June 20, 2024Historical recordClass III

East West Tea Company, LLC

Product
Organic Yogi Echinacea Immune Support, Caffeine Herbal Suppl…
Reason
Organic Yogi Echinacea Immune Support product is recalled because pesticide residues were detected above action levels.
Published
May 22, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Out of specification for assay
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason
Discoloration: Dotted and yellow spots on tablets
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason
Discoloration: Dotted and yellow spots on tablets
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 22, 2025Historical recordClass III

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

by Acella Pharmaceuticals, LLC

Reason
Subpotent drug
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 9, 2024Historical recordClass II

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

by RemedyRePack Inc.

Reason
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

by Rubicon Research Private Limited

Reason
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass I

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass I

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Published
May 15, 2024
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published
May 15, 2024
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.

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