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.