Fentanyl Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction
Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall classification, which per the severity rubric qualifies for Critical status. Class I is the FDA's highest designation for recalls involving serious health hazards.
Plain-English summary
Denver Solutions, LLC DBA Leiters Health is recalling 8,976 intravenous bags of fentanyl citrate (Item F3355, NDC 71449-072-41) distributed nationwide. The product is fentanyl citrate for intravenous use, supplied as 1000 micrograms per 100 milliliters of 0.9% sodium chloride solution.
The manufacturer initiated the recall because the semi-automated IV bag filling system can malfunction during production. When this malfunction occurs, the filling system can deliver a double dose of fentanyl citrate to individual IV bags.
The affected lots and corresponding expiration dates are Lot #2331062 (expires 02/08/2024), Lot #2331224 (expires 03/18/2024), and Lot #2331270 (expires 03/28/2024). The product was manufactured by Denver Solutions, LLC at 13796 Compark Boulevard, Englewood, Colorado 80112.
The recalled product
- Product
- FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable / IV
- Affected units
- 8,976
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 (6)
- Lot #: 2331062
- Exp. Date: 02/08/2024
- 2331224
- Exp. Date 03/18/2024
- 2331270
- Exp. Date 03/28/2024.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Denver Solutions, LLC DBA Leiters Health
See all →- SevereRocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk
FDA (Drugs) · 2025-04-30
- SevereDexmedetomidine HCl Syringes Recalled for Potential Sterility Issue
FDA (Drugs) · 2025-04-30
- SevereKetamine HCl Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-04-30
- SeverePHENYLephrine HCl Injection Syringes Recalled for Lack of Sterility
FDA (Drugs) · 2025-04-30
- HighGlycopyrrolate 1mg/5mL Syringes Recalled for Sterility Risk
FDA (Drugs) · 2025-04-30
Same hazard · dosing error
See all →- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
- CriticalPediatric ALS organizers recalled over potentially harmful drug dosing errors
FDA (Food) · 2026-02-04
Similar recalls
- HighFentanyl Citrate IV Bags Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-08-17
- HighFDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations
FDA (Drugs) · 2023-03-15
- HighFDA Recalls Compounded Fentanyl Citrate IV Bags Due to Sterility Concerns
FDA (Drugs) · 2025-02-26
- ModerateOxytocin IV Bags Recalled Due to Labeling Defect
FDA (Drugs) · 2023-11-01
- HighFDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
FDA (Drugs) · 2023-03-15
- SevereFDA Recalls Fentanyl IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09