Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
Hospira is recalling 47,400 vials of Fentanyl Citrate Injection because loose or missing vial crimps raise concerns about 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or other adverse health consequences.
Plain-English summary
Hospira, Inc. is recalling 47,400 vials of Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL (50 mcg/mL), 50 mL Single-dose Fliptop Vial. The product is identified by NDC 0409-9094-61, Lot # 39474DK, and an expiry date of 03/01/2016. The recall was initiated due to a lack of assurance of sterility, specifically because the fliptop vial crimps are loose or missing.
The affected product was distributed nationwide in the United States. Fentanyl Citrate is a prescription-only medication administered via intramuscular or intravenous routes. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific lot number and expiry date listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 47,400
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 (2)
- Lot #: 39474DK
- Expiry: 03/01/2016.
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) · 2014-12-17
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 Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX 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 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) · 2014-12-17
- SeverePfizer Recalls Fentanyl Citrate Injections Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-08-12
- SeverePfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects
FDA (Drugs) · 2020-02-19
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- SevereHospira Recalls Furosemide Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-03-06
- SevereHospira Recalls Diazepam Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-06-12