Testosterone Cypionate and Anastrozole Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy (Talon Compounding Pharmacy) is recalling testosterone cypionate 200mg/anastrozole 0.25mg/mL injectable in oil due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
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: The source indicates FDA Class II classification. Injectable products with lack of sterility assurance carry substantial risk of serious infection or sepsis if used by patients. Although no illnesses are reported in the source, Class II designation with a non-sterile injectable product meets the "Severe" threshold per the rubric.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy (located at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247), is recalling testosterone cypionate 200mg/anastrozole 0.25mg/mL in oil injectable (prescription only) due to lack of assurance of sterility.
The affected product was distributed across the United States, including Washington, D.C. and Puerto Rico. The recalled lots are T1006092021:18 (beyond-use date 12/06/2021) and T1009022021:89 (beyond-use date 03/01/2022). A total of 4 vials are affected.
Patients who have received this product should consult their healthcare provider immediately. Do not use the product. Contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247 or contact the FDA if you have any questions.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 4
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: T1006092021:18 BUD: 12/06/2021
- T1009022021:89 BUD: 03/01/2022
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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighInjectable testosterone-anastrozole mixture recalled for sterility assurance failure
FDA (Drugs) · 2022-04-06
- SevereTestosterone Cypionate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- HighCompounded Testosterone/Anastrozole Injectable Vials Recalled for Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighTestosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance Defect
FDA (Drugs) · 2022-04-06
- SevereTestosterone Cypionate and Anastrazole Injection Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls Testosterone Cypionate and Anastrazole Injection Due to Sterility Concerns
FDA (Drugs) · 2015-09-23