Asteria Health Recalls Testosterone Sterile Pellets Due to Potential Metal Particulate Matter

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 discovery of a foreign substance, specifically the potential presence of metal particulate matter, within the product. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall affects 153,498 units of the following product distributed nationwide across the United States:

• Product Name: Testosterone, 100 mg, 1 Sterile Pellet
• NDC Number: 79559-1100-32
• Manufacturer: Asteria Health, 432 Industrial Ln, Birmingham, AL 35211
• Affected Lot Numbers and Expiration Dates:
  • Lot 251000132 (Exp. 06/16/2026)
  • Lot 251000142 (Exp. 06/30/2026)
  • Lot 251000144 (Exp. 07/14/2026)
  • Lot 251000146 (Exp. 07/21/2026)
  • Lot 251000162 (Exp. 08/16/2026)
  • Lot 251000163 (Exp. 08/16/2026)
  • Lot 251000167 (Exp. 08/22/2026)
  • Lot 251000177 (Exp. 09/12/2026)

What You Should Do

Healthcare providers and consumers who have the affected lots should immediately stop using the product. Asteria Health notified its customers of the recall via letter starting on January 26, 2026. For further information regarding returns or specific instructions, parties should contact F.H. INVESTMENTS, Inc. at their Birmingham, Alabama location.

Why This Matters

The presence of metal particulate matter in a sterile drug product intended for implantation poses a serious health risk, as it can lead to inflammation, irritation, or other adverse tissue reactions at the site of administration.

Source

This information is based on official recall data from the FDA under recall number D-0323-2026.