Official recall notice

FDA DrugClass IINotable

Buprenorphine Hydrochloride Injection /mL Recall (Oct 2026)

Product: Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

Recall date
2026-10-07
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Crystallization

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Product description

Crystallization

Affected products

Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027

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