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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 841–860 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall initiated
July 7, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall initiated
July 7, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall initiated
July 7, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall initiated
July 7, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall initiated
July 7, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

by Lannett Company Inc.

Reason
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Recall initiated
August 11, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide within the USA

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Drug Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

by Amerisource Health Services LLC

Reason
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Recall initiated
July 29, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01

by Cardinal Health Inc.

Reason
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Recall initiated
August 5, 2025
Reported by FDA
September 3, 2025
Distribution
KS

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Drug Recall Ongoing Historical recordClass II

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

by Baxter Healthcare Corporation

Reason
Discoloration
Recall initiated
August 20, 2025
Reported by FDA
September 3, 2025
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04

by VIONA PHARMACEUTICALS INC

Reason
Discoloration
Recall initiated
August 12, 2025
Reported by FDA
August 27, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Recall initiated
August 20, 2025
Reported by FDA
August 27, 2025
Distribution
Product was distributed nationwide within the United States.

View recall →

Drug Recall Ongoing Historical recordClass III

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.

by Cipla USA, Inc.

Reason
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Recall initiated
July 24, 2025
Reported by FDA
August 27, 2025
Distribution
U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass III

Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2

by Haleon US Holdings LLC

Reason
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Recall initiated
August 5, 2025
Reported by FDA
August 27, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

by PFIZER INC

Reason
Lack of Assurance of Sterility.
Recall initiated
August 4, 2025
Reported by FDA
August 27, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.

by PFIZER INC

Reason
Lack of Assurance of Sterility.
Recall initiated
August 4, 2025
Reported by FDA
August 27, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01

by Taizhou Kangping Medical Science And Technology Co., Ltd.

Reason
Lack of Assurance of Sterility.
Recall initiated
July 22, 2025
Reported by FDA
August 27, 2025
Distribution
NY

View recall →

Drug Recall Ongoing Historical recordClass II

Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)

by Merck & Co. Inc

Reason
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Recall initiated
July 21, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA and PR.

View recall →

Drug Recall Ongoing Historical recordClass II

Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10

by Westminster Pharmaceuticals LLC

Reason
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Recall initiated
August 6, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Recall initiated
August 7, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Recall initiated
August 6, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide within the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.