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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 2,021–2,040 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

by Apotex Corp.

Reason
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated
November 1, 2023
Reported by FDA
December 6, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

by Apotex Corp.

Reason
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated
November 1, 2023
Reported by FDA
December 6, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

by Apotex Corp.

Reason
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated
November 1, 2023
Reported by FDA
December 6, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

by Apotex Corp.

Reason
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated
November 1, 2023
Reported by FDA
December 6, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1

by Cardinal Health Inc.

Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated
October 31, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1

by Cardinal Health Inc.

Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated
October 31, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)

by Cardinal Health Inc.

Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated
October 31, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1

by Cardinal Health Inc.

Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated
October 31, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1

by Cardinal Health Inc.

Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated
October 31, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1

by Cardinal Health Inc.

Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated
October 31, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).

by Exela Pharma Sciences LLC

Reason
Presence of Particulate Matter: Silicone
Recall initiated
October 18, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).

by Exela Pharma Sciences LLC

Reason
Presence of Particulate Matter: Silicone
Recall initiated
October 18, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.

by Exela Pharma Sciences LLC

Reason
Presence of Particulate Matter: Silicone
Recall initiated
October 18, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)

by ITF PHARMA INC

Reason
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Recall initiated
October 20, 2023
Reported by FDA
November 29, 2023
Distribution
Distributed to one distributor in TN who may have further distributed.

View recall →

Drug Recall Terminated Historical recordClass III

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.

by NCS Healthcare of Kentucky Inc

Reason
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Recall initiated
October 27, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.

by NCS Healthcare of Kentucky Inc

Reason
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Recall initiated
October 27, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Recall initiated
October 23, 2023
Reported by FDA
November 29, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03

by Integrity Bio-Chemicals LLC

Reason
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiated
October 18, 2023
Reported by FDA
November 29, 2023
Distribution
Distributed to one distributor in OK with possibility of further distribution

View recall →

Drug Recall Terminated Historical recordClass II

Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03

by Integrity Bio-Chemicals LLC

Reason
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiated
October 18, 2023
Reported by FDA
November 29, 2023
Distribution
Distributed to one distributor in OK with possibility of further distribution

View recall →

Drug Recall Terminated Historical recordClass II

Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03

by Integrity Bio-Chemicals LLC

Reason
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiated
October 18, 2023
Reported by FDA
November 29, 2023
Distribution
Distributed to one distributor in OK with possibility of further distribution

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.