Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Is Sermorelin recalled?
Yes — there is an active recall. 13 ongoing FDA recalls mention Sermorelin (92 total). Check the affected lots below.
Most common reason: Sterility / contamination (80 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sermorelin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sermorelin recalls on record
none so far in 2026; 92 on record, newest first
Class II · Moderate risk
Sermorelin Acetate 1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial
Lack of assurance of sterility.
Class II · Moderate risk
Sermorelin Acetate 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Sermorelin Acetate
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Class II · Moderate risk
Sermorelin/Glycine 2000mcg/5mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin/Glycine 2000mcg/5mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin 2000mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate 9mg/Ipamorelin 9mg - Lyophilized 9mg/9mg Vial
Lack of assurance of sterility
Class II · Moderate risk
Sermorelin Acetate 6mg/Ipamorelin 6mg - Lyophilized 6mg/6mg Vial
Lack of assurance of sterility
Class II · Moderate risk
Sermorelin Acetate 15mg/Ipamorelin 15mg - Lyophilized 15mg/15mg Vial
Lack of assurance of sterility
Class II · Moderate risk
Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate 9 mg / Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate 3 mg / Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate 9 mg/ 3 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin 9 mg / GHRP6
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin/GHRP-2 &6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 &6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 & 6
Lack of Sterility Assurance.
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