Estradiol Valerate Injectable Injection Lacks Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 50 mg/mL injectable due to lack of assurance of sterility. The affected product is a prescription injection distributed across the United States, Puerto Rico, and Washington, D.C.
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: This is an FDA Class II recall of a sterile injectable drug product. Lack of sterility assurance in injectable medications presents a serious risk of infection or sepsis, which can result in hospitalization or serious injury. Class II recalls with this type of hazard profile meet the "Severe" threshold.
Plain-English summary
Talon Compounding Pharmacy (Vita Pharmacy, LLC) is recalling Estradiol Valerate 50 mg/mL in Ethyl Oleate Injectable due to lack of assurance of sterility. The product is a prescription-only injectable medication.
The affected product includes two lots: Lot 09162021:29 with Beyond-Use Date (BUD) of 03/15/2022, and Lot 09132021:31 with BUD of 03/12/2022. A total of 15 vials were distributed. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients currently using this product should consult their healthcare provider or pharmacist regarding continued use and appropriate next steps. Healthcare providers and patients should report any adverse events to the FDA MedWatch program or contact Talon Compounding Pharmacy directly.
The recalled product
- Product
- ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ 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
- lack-of-sterility
- contamination-risk
- injection-safety
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: 09162021:29 BUD: 03/15/2022
- 09132021:31 BUD: 03/12/2022
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27