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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 6,701–6,720 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recall initiated
September 3, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10

by Pfizer Inc.

Reason
Labeling: Incorrect or Missing Lot and/or expiration date.
Recall initiated
November 27, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide within the United States including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Recall initiated
December 2, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

by AuroMedics Pharma LLC

Reason
Discoloration: Product complaints of discoloration after reconstitution of vials.
Recall initiated
November 25, 2019
Reported by FDA
December 18, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

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.