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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 10,201–10,220 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion 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

Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-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

Methylene Blue (PF) 10 mg/mL (1%) Injectable 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

Liothyronine SR (T3) 20 mcg 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

Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% 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

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxocobalamin 1 mg/mL 30 mL 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

Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 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

Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment 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

Human Chorionic Gonadotropin 20,000 iu/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

Human Chorionic Gonadotropin 11,000 iu/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

Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, 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

Human Chorionic Gonadotropin 5,000 iu/ 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

Human Chorionic Gonadotropin 2,500 Units, 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

Human Chorionic Gonadotropin 500 iu 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

Estriol 0.1% (1 mg/gm) 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

Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 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

View recall →

Drug Recall Terminated Historical recordClass II

Chloramphenicol 500 mg Amphotericin 50 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

View recall →

Drug Recall Terminated Historical recordClass II

Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, 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

Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg 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

Benzo/Lido/Tetracaine 20%-8%-8% 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 →

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.