Testosterone Injectable Pellets Recalled for Potential Metal Particulate Matter
Asteria Health is recalling one lot of testosterone pellets due to potential presence of metal particulate matter. Affected patients should contact their healthcare provider.
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: This is an FDA Class II recall of a sterile injectable drug product with potential for foreign material contamination. While no illnesses or injuries have been reported, metal particulate matter in a sterile injection product represents a risk-of-harm scenario.
Plain-English summary
F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling Testosterone, 303 mg, 1 Sterile Pellet product due to a quality issue. The recalled product is distributed nationwide in the United States.
The FDA identified potential presence of metal particulate matter in the recalled lot. This foreign material could pose a risk to patient safety if injected.
The affected lot is #251000124, which expires on June 2, 2026. Patients who have received injections from this lot should contact their healthcare provider immediately for evaluation and guidance on next steps.
The recalled product
- Product
- Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Injectable
- Hazard
- metal-particulate
- 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 (2)
- Lot#: 251000124
- Exp. 06/02/2026.
Distribution
Distributed nationwide across the United States.
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