Testosterone Cypionate Injection Recalled Due to Manufacturing Defect
Eugia US LLC is recalling 36,816 vials of Testosterone Cypionate Injection nationwide due to a manufacturing defect where crystals fail to redissolve after warming and shaking, potentially affecting proper drug administration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall involving a manufacturing defect that directly impairs usability and safe administration. While no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where the crystalline defect compromises proper intramuscular injection and dosage consistency.
Plain-English summary
Eugia US LLC, in cooperation with the FDA, is recalling 36,816 vials of Testosterone Cypionate Injection, USP (200 mg/mL) due to a manufacturing defect. The affected lot (1TC24075A, expires 11/30/2026) has been found to have crystals that do not redissolve into solution even after recommended warming and shaking procedures.
This manufacturing defect raises concern about whether the product can be properly administered via intramuscular injection and whether patients will receive the intended dose. The defect was identified through complaints regarding the product's quality.
The product was distributed nationwide in the United States. Patients currently using this medication should consult with their healthcare provider or pharmacist about their supply. Do not use vials with visible undissolved crystals.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectables
- Hazard
- undissolved-crystals
- dosage-inconsistency
- injection-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1TC24075A
- Exp 11/30/2026.
UPCs (3)
- 0355150276011
- 0355150278015
- 0355150277018
Distribution
Distributed nationwide across the United States.
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