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

What Happened

F.H. INVESTMENTS, Inc. (dba Asteria Health), based in Birmingham, Alabama, has initiated a voluntary recall of Estradiol sterile pellets. The recall was issued due to the potential presence of a foreign substance, specifically metal particulate matter, within the product. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall affects ESTRADIOL, 10 mg, 1 Sterile Pellet, with NDC 79559-3010-32. A total of 24,099 pellets are included in this recall. The affected products were distributed nationwide in the USA and include the following lot numbers and expiration dates:

• Lot#: 253000132, Exp. 06/16/2026
• Lot#: 253000139 and 253000140, Exp. 07/21/2026
• Lot#: 253000150, Exp. 08/08/2026
• Lot#: 253000151, Exp. 08/16/2026
• Lot#: 253000161 and 253000162, Exp. 09/12/2026

What You Should Do

Consumers and healthcare providers should immediately stop using the affected lots. The firm initiated notification to customers via letter on January 26, 2026. For questions regarding the return or replacement of these products, contact F.H. INVESTMENTS, Inc. (dba Asteria Health) at 432 Industrial Ln, Birmingham, AL 35211-4465.

Why This Matters

The presence of metal particulate matter in a sterile pellet product poses a risk of injury or adverse health consequences to patients. This recall is intended to prevent potential complications associated with the administration of contaminated medication.

Source

Information provided by the FDA under Recall Number D-0308-2026.