Recalls / Class II
Class IID-0310-2026
Product
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
- Affected lot / code info
- Lot#: 253000118, Exp. 02/21/2026; 253000145, Exp. 08/02/2026; 253000146, Exp. 06/30/2026, 253000167, Exp. 09/23/2026.
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
- 14,848 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-0310-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.