Estradiol Pellets Recalled for Potential Metal Particulate Contamination
F.H. INVESTMENTS, Inc. is recalling Estradiol 10 mg sterile pellets nationwide due to potential presence of metal particulate matter. The recall affects multiple lot numbers with expiration dates from June through September 2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for potential metal particulate contamination in an injectable medication. Per the severity rubric, this qualifies as High (3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
F.H. INVESTMENTS, Inc. (doing business as Asteria Health) is recalling Estradiol 10 mg sterile pellets due to the potential presence of metal particulate matter in the product. The affected pellets are manufactured for injection and distributed nationwide in the United States.
A total of 24,099 pellets are subject to this recall. The affected lot numbers are: 253000132 (expires 06/16/2026), 253000139, 253000140 (expire 07/21/2026), 253000150 (expires 08/08/2026), 253000151 (expires 08/16/2026), and 253000161, 253000162 (expire 09/12/2026).
Consumers and healthcare providers in possession of affected Estradiol pellets should discontinue use and contact F.H. INVESTMENTS, Inc. for instructions on product return or disposal. Healthcare providers should review patient records to identify patients who may have received these pellets and determine appropriate follow-up care.
The recalled product
- Product
- ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Hormone / Injectable
- Hazard
- foreign-material
- metal-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
Distribution
Distributed nationwide across the United States.
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