Fentanyl Citrate

Fentanyl Citrate recalls: 5 FDA reports

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

5Reports
0Class I
0Ongoing
2020-08-12Most 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 II3
Class III2

By year reported

YearReports
20142
20152
20201
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.

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distribu

D-1446-2020  ·  Class II  ·  reported 2020-08-12  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Product
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Where it went
United States including Puerto Rico
How much
19,144 vials

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative

D-1139-2015  ·  Class III  ·  reported 2015-06-24  ·  Terminated

Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Product
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Where it went
Nationwide
How much
14,649 Cartons

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intrav

D-0420-2015  ·  Class III  ·  reported 2015-04-01  ·  Terminated

Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing.
Product
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Where it went
Nationwide
How much
445,475 Vials

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25

D-0294-2015  ·  Class II  ·  reported 2014-12-17  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility; improperly crimped fliptop vials
Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
Where it went
Nationwide
How much
62,650 vials

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, R

D-1433-201  ·  Class II  ·  reported 2014-07-23  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Where it went
U.S. Nationwide
How much
47,400 vials
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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