Asteria Health Recalls Estradiol 15 mg Sterile Pellets Due to Potential Metal Contamination

What Happened

F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of Estradiol 15 mg 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 14,848 units of ESTRADIOL, 15 mg, 1 Sterile Pellet. The product is identified by NDC 79559-3015-32 and was distributed nationwide in the United States. The following lot numbers and expiration dates are included in the recall:

• Lot#: 253000118, Exp. 02/21/2026
• Lot#: 253000145, Exp. 08/02/2026
• Lot#: 253000146, Exp. 06/30/2026
• Lot#: 253000167, Exp. 09/23/2026

What You Should Do

Healthcare providers and consumers should immediately stop using the affected lots. Asteria Health began notifying customers of the issue via letter on January 26, 2026. For information regarding product returns or to report concerns, contact the firm at 432 Industrial Ln, Birmingham, AL 35211.

Why This Matters

The presence of metal particulate matter in a sterile drug product intended for administration poses a serious health risk, as it can lead to internal injury or adverse physiological reactions.

Source

Recall information provided by the FDA (Recall Number: D-0310-2026).