FDA Recalls Testosterone Pellets Nationwide for Metal Contamination
F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling 62,581 testosterone pellets due to potential metal particulate matter contamination. The affected product was distributed nationwide, and the FDA classified this as a Class II recall.
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: The FDA classified this as a Class II recall due to potential metal particulate matter contamination in a sterile injectable/implant drug product. While no illnesses or injuries have been reported, this represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
F.H. INVESTMENTS, Inc., operating as Asteria Health, is recalling testosterone pellets due to the potential presence of metal particulate matter. The recall affects 62,581 units of testosterone 87.5 mg sterile pellets (NDC 79559-1087-32) that were distributed nationwide in the United States.
The product was recalled because metal particulate matter was identified as a potential contaminant in the sterile pellets. This is classified as a Class II recall by the U.S. Food and Drug Administration.
The affected product includes the following lot numbers: 251000145 (expiration date 07/14/2026), 251000161 (expiration date 08/16/2026), and 251000175 (expiration date 09/08/2026). The product was manufactured by Asteria Health located at 432 Industrial Ln, Birmingham, AL 35211.
Anyone who has this product should contact their healthcare provider or the manufacturer for additional information. The presence of metal contamination in an implanted drug product poses a potential risk and warrants medical evaluation if exposure has occurred.
The recalled product
- Product
- Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Testosterone implant
- Hazard
- 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 (6)
- Lot#: 251000145
- Exp. 07/14/2026
- 251000161
- Exp. 08/16/2026
- 251000175
- Exp. 09/08/2026. .
Distribution
Distributed nationwide across the United States.
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