Asteria Health Issues Nationwide Recall of Estradiol Sterile Pellets Due to Metal Contamination Concerns
F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling over 2,400 Estradiol 25 mg sterile pellets because they may contain foreign metal particulate matter.
What Happened
F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of its Estradiol sterile pellets. The recall was prompted by the potential presence of a foreign substance, specifically metal particulate matter, within the product. This Class II recall was initiated by the firm via letter on January 26, 2026.
Which Products Are Affected
The recall affects the following specific product lot distributed nationwide in the United States:
- Product Name: ESTRADIOL, 25 mg, 1 Sterile Pellet
- Manufacturer: Asteria Health (432 Industrial Ln, Birmingham, AL 35211)
- NDC Number: 79559-3025-32
- Lot Number: 253000136
- Expiration Date: 07/01/2026
- Quantity: 2,442 pellets
What You Should Do
Healthcare providers and facilities should immediately stop using and distributing the affected lot. If you have this product in your inventory, you should contact Asteria Health at their Birmingham, Alabama facility (432 Industrial Ln, Birmingham, AL 35211) for instructions regarding the return or disposal of the pellets. Patients who have concerns or believe they have received an implant from the affected lot should contact their healthcare provider.
Why This Matters
The presence of foreign metal particulates in a sterile drug product intended for implantation poses a significant health risk. Foreign matter in such products can lead to localized inflammation, tissue damage, or other adverse medical complications at the site of administration.
Source
Information provided by the FDA. Recall Number: D-0314-2026.
Source: FDA Official Notice