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Recall totals

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

37,326
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,859
Class I recallsReasonable probability of serious health consequences
24,440
Class II recallsTemporary or medically reversible health consequences
2,900
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 2,095 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 II24,440
Class I9,859
Class III2,900
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,440
Class I9,859
Class III2,900
Not Yet Classified2

Showing 5,221–5,240 of 17,324 recalls

FDA Recall TerminatedTerminated: June 21, 2023Historical recordClass II

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

by Medique Products

Reason
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 21, 2023Historical recordClass II

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6

by Medique Products

Reason
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: March 29, 2024Historical recordClass III

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent drug
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

by Mayne Pharma Inc

Reason
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Published
January 26, 2022
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 20, 2023Historical recordClass III

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: November 15, 2022Historical recordClass I

SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

by Lohxa, LLC

Reason
Microbial Contamination of Non-Sterile Product
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: August 15, 2023Historical recordClass II

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.

by Ingenus Pharmaceuticals Llc

Reason
CGMP Deviations
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 1, 2023Historical recordClass II

Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ

by Teva Pharmaceuticals USA

Reason
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Published
January 26, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: September 17, 2022Historical recordClass II

Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.

by Akorn, Inc.

Reason
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Published
January 19, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: December 4, 2023Historical recordClass I

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Published
January 19, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: September 28, 2023Historical recordClass II

Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02

by Padagis US LLC

Reason
Defective Delivery System
Published
January 19, 2022
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: December 2, 2022Historical recordClass II

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1

by Exela Pharma Sciences LLC

Reason
Lack of Assurance of Sterility
Published
January 19, 2022
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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