Testosterone pellets recalled for potential metal particulate matter
Asteria Health is recalling testosterone sterile pellets (NDC 79559-1062-32) due to potential metal particulate matter contamination. Patients with affected lot 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 for potential metal particulate matter in an injectable steroid. No reported illnesses or adverse events are documented in the source, placing this in the High category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The product being recalled is Testosterone 62.5 mg sterile pellets manufactured by F.H. INVESTMENTS, Inc. (dba Asteria Health), located at 432 Industrial Ln, Birmingham, AL 35211. The affected lot is #251000125 with an expiration date of 06/02/2026. Approximately 1,758 pellets have been distributed nationwide.
The recall was initiated due to the potential presence of metal particulate matter in the product. While no illnesses or injuries have been reported to date, metal particles in an injectable medication pose a serious risk of harm to patients.
Patients who have received doses from this lot should contact their healthcare provider immediately to discuss whether they may have been exposed and what monitoring or follow-up care may be necessary.
The recalled product
- Product
- Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
- Manufacturer
- F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Category
- Drug — Injectable hormone
- Hazard
- metal-particulate
- foreign-substance
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#: 251000125
- Exp. 06/02/2026.
Distribution
Distributed nationwide across the United States.
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