FDA Drug Recalls

Recalls / Class II

Class IID-0307-2026

Product

ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.

Affected lot / code info
Lot#: 253000127, Exp. 06/09/2026; 253000133, Exp. 06/17/2026; 253000138, Exp. 07/14/2026; 253000141, Exp. 07/21/2026; 253000144, Exp. 07/28/2026; 253000147, Exp. 08/05/2026; 253000148, Exp. 08/07/2026; 253000149, Exp. 08/08/2026; 253000152, 253000153, Exp. 08/22/2026; 253000156, Exp. 09/03/2026; 253000157, Exp. 09/04/2026; 253000159, Exp. 09/05/2026; 253000164, Exp. 09/16/2026; 253000165, Exp. 09/19/2026; 253000170, Exp. 10/03/2026.

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
50,990 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-0307-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls