Official recall notice

FDA DrugClass IINotable

Sermorelin Acetate /ML Injectable Recall (Oct 2026)

Product: 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

Recall date
2026-10-14
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.

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