Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable 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 FDA classified this as a Class II recall for a sterility assurance failure in an injectable drug product. Non-sterile injections pose a significant risk of serious infection and hospitalizations; this meets the Severe criterion for FDA Class II with significant injury risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable in ethyl oleate oil because the firm cannot assure that the product meets sterility requirements. The recalled product is a compounded injectable medication identified by Lot 04262021:43 with a Beyond Use Date of 10/23/2021.
This product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Consumers or healthcare providers who have received this product should contact their healthcare provider or pharmacist for guidance on whether they have received the affected lot.
The recalled product
- Product
- ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 2
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: 04262021:43 BUD: 10/23/2021
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
- SevereEstradiol Valerate Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereEstradiol Valerate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SevereEstradiol Valerate Injectable Vials Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereEstradiol Valerate Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
- SevereClinical Specialties Compounding Pharmacy Recalls Estradiol Valerate Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SevereFDA Recalls Estradiol Valerate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-18