Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 20 mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class II recall. Lack of sterility assurance for an injectable drug presents a serious risk of infection or other adverse outcomes to patients receiving the product, meeting the threshold for a Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247, is recalling testosterone cypionate 20 mg/mL injectable in ethyl oleate due to lack of assurance of sterility. The affected product includes seven vials distributed across the United States, Washington D.C., and Puerto Rico.
The recall includes the following lot numbers and beyond-use dates: T0507152021:64 (BUD 01/11/2022), T0507232021:35 (BUD 01/19/2022), and T0507292021:15 (BUD 01/25/2022).
Consumers who have received this prescription product should contact their healthcare provider or pharmacy for guidance. This is a prescription-only medication, and patients should not discontinue use without medical advice.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 20MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Hazard
- sterility-assurance
- injection-safety
- infection-risk
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 (3)
- Lot: T0507152021:64 BUD: 01/11/2022
- T0507232021:35 BUD: 01/19/2022
- T0507292021:15 BUD: 01/25/2022
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27