Asteria Health Issues Nationwide Recall of Testosterone Sterile Pellets Due to Metal Particulates
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F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling over 194,000 testosterone sterile pellets 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 its Testosterone 200 mg sterile pellets. The recall was prompted by the discovery of a foreign substance, specifically the potential presence of metal particulate matter within the product. The recall is currently classified as Class II by the FDA.
Which Products Are Affected
The recall affects 194,336 units distributed nationwide in the United States. The specific product details are as follows:
- Product Name: Testosterone, 200 mg, 1 Sterile Pellet
- Manufacturer: Asteria Health (432 Industrial Ln, Birmingham, AL 35211)
- NDC: 79559-1200-43
- Recall Number: D-0324-2026
- Affected Lot Numbers and Expiration Dates:
- Lot 251000127 (Exp. 06/03/2026)
- Lot 251000128 (Exp. 06/05/2026)
- Lots 251000133, 251000134, 251000135 (Exp. 06/16/2026)
- Lots 251000138, 251000139, 251000140, 251000141 (Exp. 06/25/2026)
- Lots 251000147, 251000148, 251000149 (Exp. 07/28/2026)
- Lots 251000156, 251000157 (Exp. 08/08/2026)
- Lots 251000164, 251000165, 251000166 (Exp. 08/22/2026)
- Lot 251000169 (Exp. 08/29/2026)
- Lots 251000171, 251000172 (Exp. 09/03/2026)
- Lot 251000180 (Exp. 09/19/2026)
What You Should Do
Healthcare providers and consumers should immediately stop using the affected lots listed above. The firm initiated the recall via notification letters sent to distributors and customers. For questions regarding the return of the product or to report adverse events, contact Asteria Health at their Birmingham, Alabama facility located at 432 Industrial Ln, Birmingham, AL 35211-4465.
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, infection, or other serious adverse reactions at the site of administration.
Source
Information provided by the FDA under Recall Event ID 98344.
Original source: FDA Official Notice ↗
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