Recalls / Class II

Class IID-0309-2026

Product

ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

Affected lot / code info

Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.

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

22,478 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-0309-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.