Official recall notice

FDA DrugClass IINotable

FDA Recall: Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For I

Recall date
2026-06-24
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Crystallization; identified as Buprenorphine free base

Recommended action

What to do

46,334 units

Product description

Crystallization; identified as Buprenorphine free base

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