Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 3,541–3,560 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 25, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 25, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.

by Strides Pharma Inc.

Reason
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Recall initiated
July 19, 2022
Reported by FDA
August 17, 2022
Distribution
US Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

by AVKARE Inc.

Reason
Labeling: Label Error on Declared Strength
Recall initiated
July 20, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

by CIPLA

Reason
Lack of Assurance of Sterility: Complaints received of defective container closure.
Recall initiated
August 2, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated
June 29, 2022
Reported by FDA
August 17, 2022
Distribution
Nationwide in 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.