FDA recall, , Moderate risk
Endo USA Buprenorphine Hydrochloride Injection
Buprenorphine Hydrochloride Injection contains particulate matter identified as Buprenorphine free base.
Summary by Recall Canary from the FDA notice
What happened
Endo USA, Inc., of Rochester, Michigan, recalled Buprenorphine Hydrochloride Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, due to the presence of particulate matter identified as Buprenorphine free base. The recall began March 13, 2026, and was added to the FDA's Enforcement Report on May 11, 2026. The product was distributed nationwide.
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
- 84132
- 87693
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- ENDO USA, Inc.Rochester, Michigan
- Hazard
- Foreign object
- 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
- 98610
- Recall number
- D-0527-2026
- Quantity recalled
- 34,293 vials
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
