Fentanyl Citrate Injection 5mcg (Pharmedium) – Potency Issue (2015)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot #: 15002077M, Exp 04-02-2015
Products Sold
Lot #: 15002077M, Exp 04-02-2015
Pharmedium Services, LLC is recalling fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV due to Subpotent Drug. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent Drug
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, IN, IA, OK, PA, VA, WI
Page updated: Jan 7, 2026