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Recall totals

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

37,115

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,793

Class I recallsReasonable probability of serious health consequences

24,343

Class II recallsTemporary or medically reversible health consequences

2,887

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

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 2026

Most affected stateHawaii 200 recalls mention this state

State: MP ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 16, 2026 ET

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

Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

FDA Recall Terminated Historical recordClass II

Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA

by Contract Pharmacal Corporation

Reason: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Published: February 19, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8

by Contract Pharmacal Corporation

Reason: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Published: February 19, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06

by Lupin Pharmaceuticals Inc.

Reason: Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Published: February 19, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical recordClass III

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09

by Macleods Pharma Usa Inc

Reason: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Published: February 12, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.

by Graviti Pharmaceuticals Private Limited

Reason: Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Published: February 12, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01

by Teva Pharmaceuticals USA

Reason: GMP Deviations: Product bottle may be absent of desiccant.
Published: February 12, 2020
Distribution: Nationwide

View recall →

Data last updated: September 16, 2026 ET

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.