Official recall notice

FDA DrugClass IINotable

FDA Recall: Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single

Recall date
2026-04-15
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Recommended action

What to do

54,583 syringes

Product description

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

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