Fentanyl Citrate Injection (PharMEDium) – Sterility Concern (2020)
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 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Brand
PharMEDium Services, LLC
Lot Codes / Batch Numbers
193510008D 3/17/2020 193580004D 3/25/020
Products Sold
193510008D 3/17/2020 193580004D 3/25/020
PharMEDium Services, LLC is recalling fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 m due to Firm is recalling 46 lots of various products because of a lack of sterility assurance.. 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
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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