CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report
Sermorelin Lyophilized powder for reconstitution, 10mg recalled
GenoGenix is recalling Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity Multi-Dose, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0090-2026
- FDA event ID
- 97369
- Recalling firm
- GenoGenix, Boca Raton, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2025
- FDA classified
- 21 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jul 2025 | Recall initiated by company | |
| 15 Oct 2025 | Published in enforcement report | +77 days |
| 21 Oct 2025 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Where it was distributed
US Nationwide.
Questions about this recall
Is Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity Multi-Dose recalled?
Yes. GenoGenix recalled Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity Multi-Dose on 30 Jul 2025. The recall is Class II and its status is Ongoing. Recall number D-0090-2026.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot#: GG062425-002 within expiry.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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