Asteria Health Issues Nationwide Recall of Testosterone Sterile Pellets Due to Metal Particulates

What Happened

F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of its Testosterone 200 mg 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 recall is currently classified as Class II by the FDA.

Which Products Are Affected

The recall affects 194,336 units distributed nationwide in the United States. The specific product details are as follows:

• Product Name: Testosterone, 200 mg, 1 Sterile Pellet
• Manufacturer: Asteria Health (432 Industrial Ln, Birmingham, AL 35211)
• NDC: 79559-1200-43
• Recall Number: D-0324-2026
• Affected Lot Numbers and Expiration Dates:
  • Lot 251000127 (Exp. 06/03/2026)
  • Lot 251000128 (Exp. 06/05/2026)
  • Lots 251000133, 251000134, 251000135 (Exp. 06/16/2026)
  • Lots 251000138, 251000139, 251000140, 251000141 (Exp. 06/25/2026)
  • Lots 251000147, 251000148, 251000149 (Exp. 07/28/2026)
  • Lots 251000156, 251000157 (Exp. 08/08/2026)
  • Lots 251000164, 251000165, 251000166 (Exp. 08/22/2026)
  • Lot 251000169 (Exp. 08/29/2026)
  • Lots 251000171, 251000172 (Exp. 09/03/2026)
  • Lot 251000180 (Exp. 09/19/2026)

What You Should Do

Healthcare providers and consumers should immediately stop using the affected lots listed above. The firm initiated the recall via notification letters sent to distributors and customers. For questions regarding the return of the product or to report adverse events, contact Asteria Health at their Birmingham, Alabama facility located at 432 Industrial Ln, Birmingham, AL 35211-4465.

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, infection, or other serious adverse reactions at the site of administration.

Source

Information provided by the FDA under Recall Event ID 98344.