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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 1,801–1,820 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298

by Brassica Pharma Pvt Ltd

Reason
Lack of Assurance of Sterility
Recall initiated
January 30, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Dissolution Specifications: Out of specification for dissolution.
Recall initiated
February 5, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15

by Golden State Medical Supply Inc.

Reason
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Recall initiated
February 14, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01

by Micro Labs Limited

Reason
CGMP Deviations: Out of specification for residual solvents.
Recall initiated
February 12, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.

by MCKESSON CORPORATION

Reason
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Recall initiated
February 12, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the US

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Drug Recall Completed Historical recordClass I

TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3

by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Reason
Chemical Contamination; presence of benzene.
Recall initiated
February 1, 2024
Reported by FDA
February 28, 2024
Distribution
Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.

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Drug Recall Ongoing Historical recordClass I

Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com

by Today The World

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Recall initiated
February 6, 2024
Reported by FDA
February 28, 2024
Distribution
Product distributed nationwide within the United States.

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Drug Recall Ongoing Historical recordClass I

SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683

by Today The World

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Recall initiated
February 6, 2024
Reported by FDA
February 28, 2024
Distribution
Product distributed nationwide within the United States.

View recall →

Drug Recall Ongoing Historical recordClass I

Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada

by Today The World

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Recall initiated
February 6, 2024
Reported by FDA
February 28, 2024
Distribution
Product distributed nationwide within the United States.

View recall →

Drug Recall Completed Historical recordClass II

Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01

by Henry Schein Inc. and Glove Club HSI Gloves Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Recall initiated
January 17, 2024
Reported by FDA
February 28, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass II

Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01

by Mallinckrodt Hospital Products Inc.

Reason
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recall initiated
February 6, 2024
Reported by FDA
February 28, 2024
Distribution
USA nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1

by Mallinckrodt Hospital Products Inc.

Reason
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recall initiated
February 6, 2024
Reported by FDA
February 28, 2024
Distribution
USA nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Recall initiated
January 16, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.

by Alpha Aromatics

Reason
CGMP Deviations
Recall initiated
January 25, 2024
Reported by FDA
February 28, 2024
Distribution
Product was distributed to two accounts in NC and MI

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Drug Recall Terminated Historical recordClass II

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.

by Lupin Pharmaceuticals Inc.

Reason
Labeling: Incorrect or Missing Package Insert
Recall initiated
February 5, 2024
Reported by FDA
February 28, 2024
Distribution
OH, IL, NJ

View recall →

Drug Recall Ongoing Historical recordClass II

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20

by Baxter Healthcare Corporation

Reason
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Recall initiated
January 23, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

by Neptune Resources, LLC

Reason
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated
January 12, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

by Neptune Resources, LLC

Reason
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated
January 12, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

by Neptune Resources, LLC

Reason
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated
January 12, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason
CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated
January 19, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the US

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.