Fluconazole

Fluconazole recalls: 10 FDA reports

Recalls involving Fluconazole. What was wrong with each batch, and how the FDA graded the risk.

10Reports
0Class I
0Ongoing
2017-05-24Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II10

By year reported

YearReports
20141
20151
20161
20177
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter

D-0788-2017  ·  Class II  ·  reported 2017-05-24  ·  Terminated

Why it was recalled
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Product
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
Where it went
US and foreign countries: United Arab Emirates, Colombia, and Canada
How much
113,590 bags

Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratorie

D-0689-2017  ·  Class II  ·  reported 2017-05-10  ·  Terminated

Why it was recalled
Failed Dissolution Specifications
Product
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
Where it went
Nationwide within the US
How much
914 cartons

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratorie

D-0688-2017  ·  Class II  ·  reported 2017-05-10  ·  Terminated

Why it was recalled
Failed Dissolution Specifications
Product
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
Where it went
Nationwide within the US
How much
2,341 cartons

Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 5

D-0451-2017  ·  Class II  ·  reported 2017-02-08  ·  Terminated

Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Product
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Where it went
Nationwide
How much
59,440 blister cards

Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, R

D-0449-2017  ·  Class II  ·  reported 2017-02-08  ·  Terminated

Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Product
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Where it went
Nationwide
How much
a) 2472 bottles, b) 780 bottles

Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles,

D-0450-2017  ·  Class II  ·  reported 2017-02-08  ·  Terminated

Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Product
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Where it went
Nationwide
How much
a) 42,984 and b) 7,764 bottles

Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles,

D-0452-2017  ·  Class II  ·  reported 2017-02-08  ·  Terminated

Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Product
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Where it went
Nationwide
How much
a) 38,832 and b) 5,064 bottles

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter

D-0206-2017  ·  Class II  ·  reported 2016-12-28  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Product
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.
Where it went
United States, United Arab Emirates, and Colombia
How much
30,910 bags

Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10

D-0380-2015  ·  Class II  ·  reported 2015-02-04  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Product
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
Where it went
Nationwide, United Arab Emirates, and Columbia
How much
31,130 bags

GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Dist

D-1356-2014  ·  Class II  ·  reported 2014-06-11  ·  Terminated

Why it was recalled
Defective Container: Tamper evident ring failures discovered on some bottles.
Product
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
Where it went
Nationwide, Italy and Republic of South Korea
How much
4,155 bottles
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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