Injectable Steroid Compound Recalled Due to Sterility Assurance Failure
Talon Compounding Pharmacy is recalling a testosterone cypionate combination injectable product distributed nationwide due to lack of assurance of sterility, which could pose risk of serious infection.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an injectable drug product with a direct risk of serious harm (infection from non-sterile injection). FDA Class II recalls with significant risk of serious infection or injury are classified as Severe per the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE (Lot T1009132021:38, BUD 03/12/2022) because the product lacks assurance of sterility.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Injection of a non-sterile product poses the risk of serious infection. Patients who have received this product should contact their healthcare provider immediately for evaluation and guidance.
Consumers with questions about this recall should contact Talon Compounding Pharmacy at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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 (1)
- Lot: T1009132021:38 BUD: 03/12/2022
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same manufacturer · Vita Pharmacy, LLC dba Talon Compounding Pharmacy
See all →- HighInjectable testosterone and dutasteride product recall for sterility assurance failure
FDA (Drugs) · 2021-11-17
- HighIC B Complex Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- SevereTRI-MIX Injectable by Talon Compounding Pharmacy Recalled for Sterility Assurance
FDA (Drugs) · 2021-11-17
- SevereInjectable Steroid Combination Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- HighTestosterone Bi-Blend Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighInjectable testosterone-anastrozole mixture recalled for sterility assurance failure
FDA (Drugs) · 2022-04-06
- HighCompounded Testosterone/Anastrozole Injectable Vials Recalled for Sterility Assurance
FDA (Drugs) · 2022-07-20
- High
- SevereTestosterone Cypionate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- HighCompounded Testosterone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- SevereTestosterone Cypionate and Anastrazole Injection Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23