Estradiol implant pellets recalled for potential metal contamination
F.H. INVESTMENTS (Asteria Health) is recalling Estradiol 18 mg sterile implant pellets nationwide due to potential metal particulate matter. No illnesses have been reported.
What this means for you
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 a Class II recall involving potential contamination of a sterile implantable drug product. Although no illnesses or injuries have been reported and the contamination is described as potential rather than confirmed, metal particles in an implantable hormone pellet constitute a risk-of-harm scenario meeting the High severity threshold.
Plain-English summary
F.H. INVESTMENTS, Inc., operating as Asteria Health, is recalling one lot of Estradiol 18 mg sterile pellets due to potential presence of metal particulate matter. The affected product is Estradiol, 18 mg, 1 Sterile Pellet with NDC 79559-3018-32, Lot 253000123, expiring June 2, 2026. Approximately 1,699 pellets were distributed nationwide.
The recall was initiated because of potential presence of foreign metal particles in the sterile pellets. While no illnesses or injuries have been reported, metal contamination in an implantable product could cause tissue irritation or other harm.
The affected lot was distributed nationwide in the United States. Patients who have or may have received this product should contact their healthcare provider immediately. Healthcare providers should stop dispensing this lot and quarantine remaining stock.
Consumers or healthcare providers with questions should contact the recalling firm.
The recalled product
- Product
- ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Hormone Pellet / Implant
- Hazard
- metal-particulate
- contamination
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#: 253000123
- Exp. 06/02/2026.
Distribution
Distributed nationwide across the United States.
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