Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
Hospira Inc. is recalling Fentanyl Citrate Injection vials because improperly crimped flip-top seals may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Hospira Inc. is recalling 62,650 vials of Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial. The recall is due to a lack of assurance of sterility caused by improperly crimped flip-top vials.
The affected product is identified by Lot 41-099-DK, expiration date 01MAY2016, and NDC 0409-9094-61. The product was distributed nationwide. Fentanyl Citrate is a prescription-only medication (C-II) intended for intramuscular or intravenous use.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or replacement. Consumers should not use the product if they have any concerns about the integrity of the vial seal.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 62,650
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 41-099-DK
- exp 01MAY2016
- NDC 0409-9094-61
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · FENTANYL CITRATE
- SeverePfizer Recalls Fentanyl Citrate Injections Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-08-12
- ModerateWest-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures
FDA (Drugs) · 2015-06-24
- ModerateWest-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures
FDA (Drugs) · 2015-04-01
- SevereHospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2014-07-23
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereHospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2014-07-23
- SeverePfizer Recalls Fentanyl Citrate Injections Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-08-12
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- SeverePfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects
FDA (Drugs) · 2020-02-19
- SevereHospira Recalls Diazepam Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereHospira Recalls Furosemide Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-03-06