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very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Drug · Recalled May 20, 2026
Buprenorphine Hydrochloride recall — ENDO USA, Inc.
Hazard: Crystallization; identified as Buprenorphine free base
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0527-2026
- Brand
- ENDO USA
- Classification
- Class II
- Units affected
- 34,293 vials
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Affected products
Companies & origin
- Recalling firm location
- Rochester, MI, United States
- Firm address
- 870 Parkdale Rd, 48307-1740
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
- Distribution
- USA Nationwide
- Firm notified the public via
- Letter
- FDA event ID
- 98610
- Recall initiated
- March 13, 2026
- FDA classified
- May 11, 2026
- FDA report date
- May 20, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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