Fentanyl Citrate Injection (Pharmedium) – potency loss (2015)
Class II: 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
Class II recall indicates potential for temporary health effects.
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, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
Brand
Pharmedium Services, LLC
Lot Codes / Batch Numbers
Lot Numbers: 15100054M, 15117048M, 15127063M, 15128034M, 15128044M, 15132059M, 15134032M, 15147063M, 15148055M, 151890302M, 151900130M, 151900222M, Exp between 07/15/15-10/12/15
Products Sold
Lot Numbers: 15100054M, 15117048M, 15127063M, 15128034M, 15128044M, 15132059M, 15134032M, 15147063M, 15148055M, 151890302M, 151900130M, 151900222M, Exp between 07/15/15-10/12/15
Pharmedium Services, LLC is recalling fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syri due to Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.. 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
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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 noticePage updated: Jan 7, 2026