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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 6,681–6,700 of 17,964 drug recalls

Drug Recall Ongoing Historical recordClass II

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

by Amneal Pharmaceuticals, Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
November 22, 2019
Reported by FDA
December 18, 2019
Distribution
Product was distributed throughout the United States.

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Drug Recall Ongoing Historical recordClass II

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

by Amneal Pharmaceuticals, Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
November 22, 2019
Reported by FDA
December 18, 2019
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

by Amneal Pharmaceuticals, Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
November 22, 2019
Reported by FDA
December 18, 2019
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409

by Surgery Pharmacy Services Inc

Reason
Lack of sterility assurance.
Recall initiated
May 30, 2019
Reported by FDA
December 18, 2019
Distribution
Distributed in GA, TN

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Drug Recall Terminated Historical recordClass II

Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,

by Surgery Pharmacy Services Inc

Reason
Lack of sterility assurance.
Recall initiated
May 30, 2019
Reported by FDA
December 18, 2019
Distribution
Distributed in GA, TN

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Drug Recall Terminated Historical recordClass II

Hydromorphone HCL and Clonidine 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.

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Drug Recall Terminated Historical recordClass II

Hydromorphone HCL and Bupivacaine 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.

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Drug Recall Terminated Historical recordClass II

Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine 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.

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and 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

Fentanyl Citrate and Bupivacaine 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.

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and 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

Baclofen and 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

Morphine Sulfate and Bupivacaine 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.

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Drug Recall Terminated Historical recordClass II

Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363

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

Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, 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 PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363

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 Baclofen 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

Clonidine HCL and 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 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 and Fentanyl Citrate and 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 →

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.