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Recall totals

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

37,449
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,872
Class I recallsReasonable probability of serious health consequences
24,509
Class II recallsTemporary or medically reversible health consequences
2,932
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 2,096 recalls
Most affected stateHawaii 200 recalls mention this state

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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)

  • 1,956 recalls have been announced year to date.
  • Oct 2026 was 4% higher than the previous complete period (Sep 2026: 209).
  • The highest complete period was Jun 2026 (300).
  • Nov 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 II24,509
Class I9,872
Class III2,932
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,509
Class I9,872
Class III2,932
Not Yet Classified2

Showing 9,381–9,400 of 21,307 recalls

FDA Recall TerminatedTerminated: August 4, 2022Historical recordClass II

Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11

by American Health Packaging

Reason
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 17, 2022Historical recordClass II

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

by AuroMedics Pharma LLC

Reason
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 22, 2020Historical recordClass II

New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 22, 2020Historical recordClass II

Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 22, 2020Historical recordClass II

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 17, 2020Historical recordClass III

Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.

by Par Pharmaceutical Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 8, 2021Historical recordClass II

Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.

by Pfizer Inc.

Reason
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 8, 2021Historical recordClass II

Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.

by Pfizer Inc.

Reason
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: July 29, 2022Historical recordClass II

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

by Akorn Inc

Reason
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 3, 2020Historical recordClass II

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

by Teva Pharmaceuticals USA

Reason
CGMP deviations: Product bottle may be absent of desiccant.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: November 3, 2020Historical recordClass II

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

by Teva Pharmaceuticals USA

Reason
CGMP deviations: Product bottle may be absent of desiccant.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 29, 2022Historical recordClass II

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).

by Pfizer Inc.

Reason
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.

by Zydus Pharmaceuticals USA Inc

Reason
cGMP Deviations
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 23, 2024Historical recordClass I

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

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

Reason
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Published
February 19, 2020
Distribution
Nationwide

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FDA Recall United States OngoingHistorical recordClass II

Sugar Foods Corporation

Product
Granulate Pure Cane Sugar sold under the brand names of:…
Reason
They were notified by their supplier that the product may be contaminated with foreign material.
Published
February 19, 2020
Distribution
Product was shipped to the following sta…

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FDA Recall United States TerminatedTerminated: September 28, 2020Historical recordClass I

Adm Milling

Product
Bulk flour
Reason
E.coli O26
Published
February 19, 2020
Distribution
AR CT FL IL IN MA MD MI NJ NY…

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FDA Recall United States TerminatedTerminated: September 28, 2020Historical recordClass I

Adm Milling

Product
Springup Flour Product Code 703220 in 50# bags
Reason
E.coli O26
Published
February 19, 2020
Distribution
AR CT FL IL IN MA MD MI NJ NY…

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FDA Recall United States TerminatedTerminated: September 28, 2020Historical recordClass I

Adm Milling

Product
Sir Lancelot HG Flour Unbl, Enr, Mt / Product Code: 802203…
Reason
E.coli O26
Published
February 19, 2020
Distribution
AR CT FL IL IN MA MD MI NJ NY…

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FDA Recall United States TerminatedTerminated: September 28, 2020Historical recordClass I

Adm Milling

Product
Sir Galahad flour / Product Code: 805226 in 50# bags
Reason
E.coli O26
Published
February 19, 2020
Distribution
AR CT FL IL IN MA MD MI NJ NY…

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FDA Recall United States TerminatedTerminated: September 28, 2020Historical recordClass I

Adm Milling

Product
Potentate flour / Prod Code: 802217 in 50# bags
Reason
E.coli O26
Published
February 19, 2020
Distribution
AR CT FL IL IN MA MD MI NJ NY…

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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