FDA Drugs recall ·
Buprenorphine Hydrochloride, Injection, 0.3mg/mL… recall
- Recall number
- D-0527-2026
- Date
- (initiated March 13, 2026)
- Company / brand
- Endo USA, Inc.
870 Parkdale Rd, Rochester, MI, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 34,293 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Crystallization; identified as Buprenorphine free base
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0527-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.