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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 10,181–10,200 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, 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

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin 10 B Lyophilized Vial, For IM Use, 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

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin 9 A/B Lyophilized Vial, For IM Use, 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

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin 9 Lyophilized Vial, For IM Use, 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

View recall →

Drug Recall Terminated Historical recordClass II

Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, 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

View recall →

Drug Recall Terminated Historical recordClass II

Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, 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

View recall →

Drug Recall Terminated Historical recordClass II

T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

Sincalide 5 mcg Lyophilized Vials, For IV Use, 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

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, 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

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, 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

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), 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

View recall →

Drug Recall Terminated Historical recordClass II

Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, 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

View recall →

Drug Recall Terminated Historical recordClass II

QUADMIX #18, 5 mL Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

QUADMIX #17, 5 mL Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

QUADMIX #16, 5 mL Vial, 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

View recall →

Drug Recall Terminated Historical recordClass II

Progesterone 3% 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

View recall →

Drug Recall Terminated Historical recordClass II

PrednisoLONE 10 mg Tablet, 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

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.