Asteria Health Recalls Testosterone Sterile Pellets Due to Potential Metal Contamination
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F.H. INVESTMENTS, Inc. (dba Asteria Health) has voluntarily recalled over 62,000 testosterone pellets nationwide due to the potential presence of metal particulate matter.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of several lots of its Testosterone sterile pellets. The recall was prompted by the potential presence of a foreign substance, specifically metal particulate matter, within the product. This Class II recall was officially classified by the FDA on February 11, 2026.
Which Products Are Affected
The recall affects 62,581 units of the following product:
- Product Name: Testosterone, 87.5 mg, 1 Sterile Pellet
- Brand: Asteria Health
- NDC: 79559-1087-32
- Affected Lots and Expiration Dates:
- Lot#: 251000145, Exp. 07/14/2026
- Lot#: 251000161, Exp. 08/16/2026
- Lot#: 251000175, Exp. 09/08/2026
These products were distributed nationwide across the United States.
What You Should Do
Healthcare providers and consumers should immediately stop using the affected lots listed above. The firm initiated the recall process via notification letters to its distributors and customers. For information regarding the return of affected products or to address concerns, contact Asteria Health at 432 Industrial Ln, Birmingham, AL 35211.
Why This Matters
The presence of metal particulate matter in a sterile pellet intended for medical use poses a significant health risk, as foreign substances can lead to inflammation, irritation, or other serious complications at the site of administration.
Source
Information provided by the FDA under recall number D-0322-2026.
Original source: FDA Official Notice ↗
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