Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 10,761–10,780 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Recall initiated
February 22, 2017
Reported by FDA
May 31, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547

by Fagron, Inc

Reason
cGMP Deviations: lack of quality assurance at the API manufacturer.
Recall initiated
April 6, 2017
Reported by FDA
May 31, 2017
Distribution
Nationwide in US and PR and Australia

View recall →

Drug Recall Terminated Historical recordClass II

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011

by Fagron, Inc

Reason
cGMP Deviations: lack of quality assurance at the API manufacturer.
Recall initiated
April 6, 2017
Reported by FDA
May 31, 2017
Distribution
Nationwide in US and PR and Australia

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91

by Mylan Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications
Recall initiated
June 22, 2016
Reported by FDA
May 31, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Recall initiated
March 17, 2017
Reported by FDA
May 24, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48

by Baxter Healthcare Corporation

Reason
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Recall initiated
May 15, 2017
Reported by FDA
May 24, 2017
Distribution
US and foreign countries: United Arab Emirates, Colombia, and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48

by Baxter Healthcare Corporation

Reason
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Recall initiated
May 15, 2017
Reported by FDA
May 24, 2017
Distribution
US and foreign countries: United Arab Emirates, Colombia, and Canada

View recall →

Drug Recall Terminated Historical recordClass III

Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15

by Teligent, Inc.

Reason
Superpotent Drug
Recall initiated
April 7, 2017
Reported by FDA
May 24, 2017
Distribution
TN

View recall →

Drug Recall Terminated Historical recordClass II

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

by Key Pharmacy and Compounding Center

Reason
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recall initiated
April 18, 2017
Reported by FDA
May 24, 2017
Distribution
Distributed nationwide in U.S.A., Australia and Canada.

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.