FDAHealthMarch 13, 2026
ENDO USA, Inc. — Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
⚠️ Crystallization; identified as Buprenorphine free base
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 13, 2026
USA Nationwide
What's affected?
- 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.
- Lot code
- 84132
Additional details
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 34,293 vials.
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