Asteria Health Recalls Testosterone Sterile Pellets Due to Potential Metal Contamination

What Happened

F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of several lots of its Testosterone 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 officially classified by the FDA on February 11, 2026.

Which Products Are Affected

The recall affects 62,581 units of the following product:

• Product Name: Testosterone, 87.5 mg, 1 Sterile Pellet
• Brand: Asteria Health
• NDC: 79559-1087-32
• Affected Lots and Expiration Dates:
  • Lot#: 251000145, Exp. 07/14/2026
  • Lot#: 251000161, Exp. 08/16/2026
  • Lot#: 251000175, Exp. 09/08/2026

These products were distributed nationwide across the United States.

What You Should Do

Healthcare providers and consumers should immediately stop using the affected lots listed above. The firm initiated the recall process via notification letters to its distributors and customers. For information regarding the return of affected products or to address concerns, contact Asteria Health at 432 Industrial Ln, Birmingham, AL 35211.

Why This Matters

The presence of metal particulate matter in a sterile pellet intended for medical use poses a significant health risk, as foreign substances can lead to inflammation, irritation, or other serious complications at the site of administration.

Source

Information provided by the FDA under recall number D-0322-2026.