[pending] BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0596-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Crystallization; identified as Buprenorphine free base
The recalled product
- Product
- BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Par Health USA, LLC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 82886
- exp 09/30/2026
- 89646
- exp 05/31/2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · BUPRENORPHINE HYDROCHLORIDE
- ModerateBuprenorphine Hydrochloride Injection Recall Due to Particulate Matter
FDA (Drugs) · 2026-05-20
- HighBuprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue
FDA (Drugs) · 2024-07-03
- ModerateBuprenorphine HCl Injection Recalled for Crystallization Defect
FDA (Drugs) · 2023-11-15
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08