FDA Drug Recalls

Recalls / Class II

Class IID-0308-2026

Product

ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

Affected lot / code info
Lot#: 253000132, Exp. 06/16/2026; 253000139, 253000140, Exp. 07/21/2026; 253000150, Exp. 08/08/2026; 253000151, Exp. 08/16/2026; 253000161, 253000162, Exp. 09/12/2026.

Why it was recalled

Presence of Foreign substance - potential presence of metal particulate matter

Recalling firm

Firm
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
432 Industrial Ln, N/A, Birmingham, Alabama 35211-4465

Distribution

Quantity
24,099 pellets
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2026-01-26
FDA classified
2026-02-11
Posted by FDA
2026-02-18
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0308-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.