Fluphenazine Decanoate (AuroMedics) – Solution Discoloration (2019)
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
Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
Brand
AuroMedics Pharma LLC
Lot Codes / Batch Numbers
Lot CFD190004, exp. date August 2020
Products Sold
Lot CFD190004, exp. date August 2020
AuroMedics Pharma LLC is recalling Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use due to Discoloration; Hazy solution found in one vial instead of a clear solution.. 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
Discoloration; Hazy solution found in one vial instead of a clear solution.
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