Endo USA Buprenorphine Hydrochloride Injection
Buprenorphine Hydrochloride Injection can crystallize.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Par Health USA, LLC recalled Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, manufactured for Endo USA, Malvern, PA, because of crystallization. The company began the recall on September 8, 2026, and the FDA added it to its Enforcement Report on September 29, 2026.
Summary by Recall Canary from the FDA notice.
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.
- NDC
- 42023-179-05
- Lot
- 83912
- 84234
- 84990
- 85003
- 86443
- 89909
Details
- Company began the recall
- Sold in
U.S. Nationwide
- Event ID
- 99902
- Recall No.
- D-0876-2026
- Company
- Par Health USA, LLCRochester, Michigan
- Hazard
- Product quality defect
- Quantity recalled
- 154210 bottles
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
