ENDO USA, Inc. recalls Buprenorphine Hydrochloride
- Recalling company
- ENDO USA, Inc.
- Product
- Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
- Reason
- Crystallization; identified as Buprenorphine free base
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 13, 2026
- Reported
- May 20, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 34,293 vials
- Lot / codes
- Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
- Company location
- Rochester, MI
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0527-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0527-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.