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Buprenorphine Hydrochloride Injection 0.3mg/mL
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DRUG RECALLMODERATE

Buprenorphine Hydrochloride Injection 0.3mg/mL

Endo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.

What to do

Do not use this medication. Contact your pharmacy or healthcare provider immediately if you have received this product. Return the vials to your pharmacy for proper disposal and obtain a replacement from an unaffected lot.

Posted
Updated
Recall No.
D-0527-2026
Agency
Firm
ENDO USA, Inc.
Recall ID
98610
Status
ONGOING

Why it was recalled

Presence of particulate matter: identified as Buprenorphine free base

How to identify it

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

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-05-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification