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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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Drug Recall Ongoing Historical recordClass I

Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138

by Botanical Be

Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Recall initiated: October 20, 2023
Reported by FDA: December 6, 2023
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass I

VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01

by Bayer Healthcare Pharmaceuticals Inc.

Reason: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Recall initiated: November 6, 2023
Reported by FDA: December 6, 2023
Distribution: Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.

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Drug Recall Terminated Historical recordClass II

PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

by Golden State Medical Supply Inc.

Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated: November 10, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

by Golden State Medical Supply Inc.

Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated: November 10, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

by Golden State Medical Supply Inc.

Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recall initiated: November 10, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30

by Teva Pharmaceuticals USA, Inc

Reason: OOS for viscosity
Recall initiated: November 10, 2023
Reported by FDA: December 6, 2023
Distribution: USA nationwide

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Drug Recall Terminated Historical recordClass III

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08

by VistaPharm LLC

Reason: Failed Excipient Specifications: high content of ethylene glycol (EG)
Recall initiated: October 17, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass III

Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01

by Fagron Compounding Services

Reason: Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Recall initiated: November 10, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Recall initiated: November 7, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01

by Glenmark Pharmaceuticals Inc., USA

Reason: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Recall initiated: November 7, 2023
Reported by FDA: December 6, 2023
Distribution: Nationwide

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Data last updated: November 1, 2026 ET

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.