Quick Facts at a Glance
- Recall Date
- June 12, 2026
- Hazard Level
- HIGH
- Brands
- BUPRENORPHINE HYDROCHLORIDE, Par Health USA, LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BUPRENORPHINE HYDROCHLORIDE, Par Health USA, LLC
- Model numbers
- Lot #: 82886, exp 09/30/2026, 89646, exp 05/31/2027
- UPC codes
- 42023-179, 42023-179-05
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 12, 2026
Reported by FDA DRUG
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Crystallization; identified as Buprenorphine free base
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Par Health USA, LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05. Generic: BUPRENORPHINE HYDROCHLORIDE; Brand: BUPRENORPHINE HYDROCHLORIDE. Reason: Crystallization; identified as Buprenorphine free base. Classification: Class II. Quantity: 46,334 units. Distribution: Nationwide in the USA.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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