The Recall Desk
SevereFDA (Drugs)·D-0165-2022·Announced 2021-11-17

Injectable testosterone and dutasteride recalled for lack of sterility assurance

Talon Compounding Pharmacy is recalling 21 vials of injectable testosterone cypionate/dutasteride because the manufacturer cannot assure sterility of the product. The recall affects distribution 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 classified this as a Class II recall. Lack of sterility assurance on injectable medications represents a significant risk of serious infection, which aligns with the Severe category for Class II recalls where serious harm is possible without reported illness yet being documented.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE across the United States, including Washington, D.C. and Puerto Rico. The product is a prescription-only injectable medication distributed by Talon Compounding Pharmacy in San Antonio, Texas.

The recall was initiated because the manufacturer cannot assure sterility of the product. Non-sterile injectable medications can introduce bacterial or fungal contamination that poses a serious health risk to patients.

Six lots are affected: T1006042021:53 (BUD 12/01/2021), T1008192021:83 (BUD 02/15/2022), T1005212021:52 (BUD 11/17/2021), T1009072021:35 (BUD 03/06/2022), T1007132021:61 (BUD 01/09/2022), and T1009142021:95 (BUD 03/13/2022). A total of 21 vials are affected.

Patients who have received this product should contact their healthcare provider immediately. Healthcare providers and pharmacists should stop dispensing the product and quarantine all remaining stock.

The recalled product

Product
TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Injectable / Compounded
Hazard
  • sterility-failure
  • infection-risk
  • bacterial-contamination

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 (6)

  • Lot: T1006042021:53 BUD: 12/01/2021
  • T1008192021:83 BUD: 02/15/2022
  • T1005212021:52 BUD: 11/17/2021
  • T1009072021:35 BUD: 03/06/2022
  • T1007132021:61 BUD: 01/09/2022
  • T1009142021:95 BUD: 03/13/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category