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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 Terminated Historical recordClass II

Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

by KRS Global Biotechnology, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recall initiated: November 16, 2017
Reported by FDA: January 17, 2018
Distribution: Nationwide in the USA, Bermuda, and New Zealand

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Drug Recall Terminated Historical recordClass II

Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

by KRS Global Biotechnology, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recall initiated: November 16, 2017
Reported by FDA: January 17, 2018
Distribution: Nationwide in the USA, Bermuda, and New Zealand

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Drug Recall Terminated Historical recordClass II

Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.

by KRS Global Biotechnology, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recall initiated: November 16, 2017
Reported by FDA: January 17, 2018
Distribution: Nationwide in the USA, Bermuda, and New Zealand

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Drug Recall Terminated Historical recordClass II

Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

by KRS Global Biotechnology, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recall initiated: November 16, 2017
Reported by FDA: January 17, 2018
Distribution: Nationwide in the USA, Bermuda, and New Zealand

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Drug Recall Terminated Historical recordClass II

Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

by KRS Global Biotechnology, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recall initiated: November 16, 2017
Reported by FDA: January 17, 2018
Distribution: Nationwide in the USA, Bermuda, and New Zealand

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Drug Recall Terminated Historical recordClass II

Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

by KRS Global Biotechnology, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recall initiated: November 16, 2017
Reported by FDA: January 17, 2018
Distribution: Nationwide in the USA, Bermuda, and New Zealand

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Drug Recall Terminated Historical recordClass II

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587

by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recall initiated: September 5, 2017
Reported by FDA: January 17, 2018
Distribution: IA, WI

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Drug Recall Terminated Historical recordClass II

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585

by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recall initiated: September 5, 2017
Reported by FDA: January 17, 2018
Distribution: IA, WI

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Drug Recall Terminated Historical recordClass II

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583

by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recall initiated: September 5, 2017
Reported by FDA: January 17, 2018
Distribution: IA, WI

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Drug Recall Terminated Historical recordClass II

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.

by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recall initiated: September 5, 2017
Reported by FDA: January 17, 2018
Distribution: IA, WI

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Drug Recall Terminated Historical recordClass II

Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12

by SCA Pharmaceuticals

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Recall initiated: December 7, 2017
Reported by FDA: January 17, 2018
Distribution: U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50

by Solco Healtcare US LLC

Reason: Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Recall initiated: December 4, 2017
Reported by FDA: January 17, 2018
Distribution: Product was distributed in Mason, OH.

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Drug Recall Terminated Historical recordClass II

Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10

by ALLERGAN

Reason: Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Recall initiated: December 4, 2017
Reported by FDA: January 17, 2018
Distribution: U.S.A. nationwide

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Drug Recall Terminated Historical recordClass III

Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10

by Sanofi-Aventis U.S. LLC

Reason: Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Recall initiated: December 5, 2017
Reported by FDA: January 17, 2018
Distribution: Distributed nationwide.

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Drug Recall Terminated Historical recordClass I

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

by Fresenius Kabi USA, LLC

Reason: Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Recall initiated: October 27, 2017
Reported by FDA: January 10, 2018
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30

by Pfizer Inc.

Reason: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Recall initiated: October 20, 2017
Reported by FDA: January 10, 2018
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977

by Pfizer Inc.

Reason: SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Recall initiated: October 20, 2017
Reported by FDA: January 10, 2018
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885

by Natures Supplement

Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Recall initiated: September 20, 2017
Reported by FDA: January 10, 2018
Distribution: Florida

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Drug Recall Terminated Historical recordClass II

Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Drug Recall Terminated Historical recordClass II

Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Recall initiated: August 10, 2017
Reported by FDA: January 3, 2018
Distribution: SSM Health entities in the state of MO only

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Data last updated: September 24, 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.