Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluphenazine Decanoate Injection USP 125mg/5mL Recalled by AuroMedics Pharma LLC Due to Discoloration; Hazy solution found in one vial instead...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AuroMedics Pharma LLC directly.
Affected Products
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
Quantity: 59,500 vials
Why Was This Recalled?
Discoloration; Hazy solution found in one vial instead of a clear solution.
Where Was This Sold?
Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
About AuroMedics Pharma LLC
AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report