Class II · ModerateActive recall

SERMORELIN ACETATE 1 MG/ML INJECTABLE

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?

Check your lot numberLot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.

Where it was soldNationwide within the U.S

Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / for

Carolina Infusion, LLC

Show the full FDA record

Full product label	SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland
Recalling firm	Carolina Infusion, LLC
Distribution	Nationwide within the U.S
Quantity	15 mls - in patient specific syringe doses
Recall initiated	2026-09-10
Report date	2026-10-14
Recall completed	—
Recall number	D-0020-2027
Classification	Class II
FDA status	Ongoing
Origin on file	Ridgeland SC United States

Recent drug recalls Check another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.