Testosterone Cypionate Injection Recalled for Insoluble Crystals
Eugia US LLC is recalling Testosterone Cypionate Injection due to complaints that crystals do not redissolve into solution after warming and shaking. The defect may affect product safety and efficacy.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a manufacturing defect (crystal redissolution) that may affect product efficacy, but no illnesses, injuries, or deaths are reported in the source text. The hazard is manufacturing-related and theoretical rather than inherent to the formulation.
Plain-English summary
Eugia US LLC is recalling Testosterone Cypionate Injection, USP 200mg per mL, in 1mL single-dose vials due to a cGMP (current Good Manufacturing Practice) issue. The recall involves Lot #1TC24075A with an expiration date of 11/30/2026, distributed nationwide across the USA.
The recall was initiated based on complaints that crystals in the vials do not redissolve into solution after the vials are warmed and shaken. This defect may compromise the product's safety and efficacy for patients who require this medication.
Healthcare providers and patients who have received vials from this lot should stop using them immediately. Affected individuals should contact their healthcare provider for guidance on obtaining replacement product or alternative treatment options. The product is distributed by Eugia US LLC in East Windsor, NJ, and was manufactured by Eugia Specialties Limited in Telangana State, India.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Eugia US LLC
- Affected units
- 36,816
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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