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Recall totals

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

37,066
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,786
Class I recallsReasonable probability of serious health consequences
24,313
Class II recallsTemporary or medically reversible health consequences
2,876
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 2,072 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)

  • 1,527 recalls have been announced year to date.
  • Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
  • The highest complete period was Jun 2026 (297).
  • Sep 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 II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 5,081–5,100 of 18,528 recalls

FDA Recall Completed Historical recordClass II

Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Lack of assurance of sterility.
Published
June 1, 2022
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Lack of assurance of sterility.
Published
June 1, 2022
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Lack of assurance of sterility.
Published
June 1, 2022
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Lack of assurance of sterility.
Published
June 1, 2022
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Lack of assurance of sterility.
Published
June 1, 2022
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
Lack of assurance of sterility.
Published
June 1, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

by GlaxoSmithKline LLC

Reason
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Published
June 1, 2022
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: customer complaints exceeded respective action limits.
Published
June 1, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

by Direct Rx

Reason
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Published
June 1, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

by Apotex Corp.

Reason
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Published
May 25, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

by American Health Packaging

Reason
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Published
May 25, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

by Lupin Pharmaceuticals Inc.

Reason
Failed Stability Specification
Published
May 25, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

by Pfizer Inc.

Reason
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Published
May 25, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

by Pfizer Inc.

Reason
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Published
May 25, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

by Pfizer Inc.

Reason
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Published
May 25, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43

by Fagron, Inc

Reason
Subpotent Drug
Published
May 18, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56

by Fagron, Inc

Reason
Subpotent Drug
Published
May 18, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07

by Fagron, Inc

Reason
Subpotent Drug
Published
May 18, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05

by Fagron, Inc

Reason
Subpotent Drug
Published
May 18, 2022
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04

by Fagron, Inc

Reason
Subpotent Drug
Published
May 18, 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.