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 17,721–17,740 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 20MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 40MCG INJECTABLE 100 ML 5 ML 75 ML; TRIMIX 10MG / 0.5MG / 1MCG INJECTABLE 10 ML; TRIMIX 10MG / 1MG / 5MCG INJECTABLE 10 ML; TRIMIX 10MG/1MG/0.5MCG INJECTABLE 10 ML; TRIMIX 12.5MG/0.83MG/8.33MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 12MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 9MCG INJECTABLE 10 ML 10 MLS 20 ML 30 ML 5 ML; TRIMIX 12MG/1MG/5MCG INJECTABLE 10 ML; TRIMIX 15MG / 1MG / 10MCG INJECTABLE 3 ML 5 ML; TRIMIX 22.5MG/0.83MG/3MCG INJECTABLE 10 ML; TRIMIX 22.5MG/0.83MG/8.33MCG INJECTABLE 1 ML 10 ML 15 ML 2.5 ML 3 ML 30 ML 5 ML; TRIMIX 24MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 24MG / 1MG / 18MCG INJECTABLE 10 ML; TRIMIX 25MG/ 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 28MG / 0.9MG / 37MCG INJECTABLE 5 ML; TRIMIX 30MG / 0.1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 10MCG INJECTABLE 10 ML; 120 ML 5 ML 60 MLS; TRIMIX 30MG / 0.5MG / 20MCG INJECTABLE 1.7 ML 10 ML 50 ML; TRIMIX 30MG / 0.5MG / 50MCG/ML INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 5MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 10MG / 20MCG INJECTABLE 5 ML; TRIMIX 30MG / 10MG / 60MCG INJECTABLE 10 ML 10 MLS 20 ML 5 ML; TRIMIX 30MG / 1MG / 18MCG INJECTABLE 5 ML; TRIMIX 30MG / 1MG / 2.5MCG INJECTABLE 3 ML 5 ML; TRIMIX 30MG / 1MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 3 ML 5 ML; TRIMIX 30MG / 1MG / 30MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 1MG / 50MCG INJECTABLE 10 ML 10 MLS 100 ML 5 ML; TRIMIX 30MG / 1MG / 5MCG INJECTABLE 10 ML 20 ML 5 ML; TRIMIX 30MG / 2MG / 100MCG INJECTABLE 20 ML; TRIMIX 30MG / 2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 2 ML 2.5 ML 20 ML 3 ML 5 ML 5 MLS 6 ML 60 ML; TRIMIX 30MG / 2MG / 25MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 30MCG INJECTABLE 10 ML 10 MLS 5 ML; TRIMIX 30MG / 2MG / 3MCG INJECTABLE 5 ML; TRIMIX 30MG / 2MG / 40MCG INJECTABLE 1 ML 1.25 ML 10 ML 15 ML 2 ML 2.5 ML 20 ML 20 MLS 30 ML 4 ML 40 ML 5 ML 6 ML 60 ML; TRIMIX 30MG / 4MG / 3.5MCG INJECTABLE 10 ML

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4 VIAL 8 VIAL; THIOTEPA, LYOPHILIZED 60MG INJECTABLE 2 VIAL (4 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS 8 VIALS (13 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 1 VIAL 3 VIAL 4 VIAL 7 VIAL (16 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC 90 ML (3 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML 2.3 ML 2.35 ML 20 ML 20.15 ML 20.45 ML 20.6 ML 20.9 ML 21.05 ML 21.2 ML 21.25 ML 21.45 ML 21.6 ML 21.7 ML 24.4 ML 28.1 ML (18 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML 2 ML 30 ML 5 ML; QUADMIX 30MG/1MG/20MCG/100MCG/ML INJECTABLE 10 ML 10 MLS 5 ML; QUADMIX 30MG/1MG/40MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/2MG/20MCG/100MCG/ML INJECTABLE 10 ML 2 ML 4 ML; QUADMIX 30MG/2MG/40MCG/100MCG/ML INJECTABLE 10 ML 15 ML; QUADMIX 30MG/2MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/3MG/50MCG/100MCG/ML INJECTABLE 10 ML 2.5 ML; QUADMIX 30MG/4MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/6MG/60MCG/100MCG/ML INJECTABLE 5 ML (22 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30 ML (6 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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.