FDA recall, , Moderate risk
Endo Buprenorphine HCl Injection
Buprenorphine HCl injection has crystallization identified as Buprenorphine free base.
Summary by Recall Canary from the FDA notice
What happened
Par Health USA, LLC, of Rochester, Michigan, recalled Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, due to crystallization identified as Buprenorphine free base. The recall began June 12, 2026, and was added to the FDA's Enforcement Report on June 17, 2026, with distribution nationwide in the USA. The product was manufactured for Endo USA, Malvern, PA 19355.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 42023-179-05
- Lot code
- 82886
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- Par Health USA, LLCRochester, Michigan
- Hazard
- Quality problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99237
- Recall number
- D-0596-2026
- Quantity recalled
- 46,334 units
All recalls from Par Health USA, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
