FDA-Drug2026-10-07Class IIPROCESSING DEFECT
Buprenorphine Hydrochloride injection recalled for crystallization
What this means
Par Health USA and Endo USA are recalling certain lots of Buprenorphine Hydrochloride 0.3 mg/mL injection due to crystallization in the vials. Crystallization can affect the drug's effectiveness and safety. The recall affects six specific lots distributed nationwide.
- Check the lot number and expiration date on your buprenorphine vial against the affected lots listed in this recall.
- If you have an affected lot, contact your pharmacy or healthcare provider for a replacement.
- Do not use the medication if crystallization is visible in the vial.
The agency's original wording
Hazard
Crystallization
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
154210 bottles
Manufactured in
870 Parkdale Rd, Rochester, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0876-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.