FDAFDA · Food and drugs·Recall number D-0527-2026
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Published May 20, 2026 · Recall initiated: March 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization; identified as Buprenorphine free base
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- ENDO USA, Inc.
- Distributor
- USA Nationwide
- Lot
- Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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