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.
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.
Why it was recalled
Endo USA is recalling Buprenorphine Hydrochloride Injection, 0.3mg/mL, 5×1 mL single-dose vials (NDC 42023-179-05) due to the presence of particulate matter identified as buprenorphine free base. Affected vials may contain visible or suspended particles that could pose a safety risk if administered.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
- Recall #
- D-0527-2026
Where it was sold
Distributed nationwide.
Official source
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