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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 1,901–1,920 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42

by Denver Solutions, LLC DBA Leiters Health

Reason
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiated
February 20, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass II

Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.

by Bausch Health Companies, Inc.

Reason
Subpotent Drug: Out of specification for assay
Recall initiated
February 2, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356

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

CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141

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

Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304

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

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

View recall →

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.

View recall →

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.

View recall →

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.

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.

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