Testosterone Cypionate Injection, Solution
FDA Recall NDC 55150-276
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Testosterone Cypionate (NDC 55150-276). A significant event, classified as Class II, was initiated on Apr 10, 2025 by Eugia Us Llc. The reported reason for this action was: "cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Apr 10, 2025
Apr 23, 2025
36,816 vials
Recall Profile & Regulatory Data
Event ID
96680
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Product Description
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
Batch or Lot Expiration Information
Lot# : 1TC24075A, Exp 11/30/2026.
Affected Packages Involved in this Recall
55150-276-01Product
55150-277-01Product
55150-278-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
