Estradiol Valerate Injectable Recalled Due to Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable across the United States, Washington D.C., and Puerto Rico due to lack of assurance of sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug product with a defect affecting sterility assurance. Although no illnesses or injuries are reported in the source text, a lack of sterility assurance for injectable products creates a risk of serious harm (infection, sepsis) and meets the "risk-of-harm products where injury has not yet been reported" criterion for a High severity score.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL in Ethyl Oleate 5mg/mL Injectable across the United States, including Washington D.C. and Puerto Rico. The recall affects seven vials with multiple lot numbers and expiration dates.
The product is being recalled due to lack of assurance of sterility. Patients who have received this injectable product should consult their healthcare provider regarding their treatment.
Affected lots include: 07232021:10 (BUD 01/19/2022), 04162021:56 (BUD 10/13/2021), 08172021:62 (BUD 02/13/2022), and 05272021:21 (BUD 11/23/2021). The product is a prescription injectable distributed by Talon Compounding Pharmacy in San Antonio, Texas.
The recalled product
- Product
- ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 7
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 (4)
- Lot: 07232021:10 BUD: 01/19/2022
- 04162021:56 BUD: 10/13/2021
- 08172021:62 BUD: 02/13/2022
- 05272021:21 BUD: 11/23/2021
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 · 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
- SevereEstradiol Valerate Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereEstradiol Valerate Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
- SevereEstradiol Valerate Injectable Vials Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereEstradiol Valerate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SevereEstradiol Valerate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereAdvanced Physician Solutions Recalls Estradiol Valerate Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-06-03