Asteria Health Recalls Estradiol Sterile Pellets Due to Potential Metal Contamination

What Happened

F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of its Estradiol sterile pellets. The recall was triggered by 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 was initiated by the firm via letter notification on January 26, 2026.

Which Products Are Affected

The recall involves 1,699 units of the following product distributed nationwide in the United States:

• Product Name: ESTRADIOL, 18 mg, 1 Sterile Pellet
• NDC: 79559-3018-32
• Lot Number: 253000123
• Expiration Date: 06/02/2026
• Manufacturer: Asteria Health, 432 Industrial Ln, Birmingham, AL 35211

What You Should Do

Healthcare providers and consumers who have the affected lot of Estradiol pellets should immediately cease use of the product. Asteria Health notified customers of the recall through a formal letter. For information regarding the return process or to report adverse events, consumers should contact F.H. INVESTMENTS, Inc. at their Birmingham, Alabama location.

Why This Matters

The presence of foreign metal particulate matter in a sterile pellet intended for medical use poses a risk of irritation or injury at the administration site. Ensuring the purity of sterile medications is critical for patient safety.

Source

Information provided by the FDA under Recall Number D-0311-2026.