ENDO USA, Inc. recalls Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malver…
- Recall date
- March 13, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0527-2026
- FDA classification
- Class II
- Brand / firm
- ENDO USA, Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
Presence of particulate matter: identified as Buprenorphine free base
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
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