FDAMarch 13, 2026drug

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Crystallization; identified as Buprenorphine free base

What to do

FDA enforcement status: Ongoing

Brands named

endo

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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