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.
Recall at a glance
- Quantity recalled
- 34,293 vials
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
- Strength
- 0.3 mg
- NDC / UPC
- NDC 42023-179-05
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-05-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification