HIGHFDA DRUG

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

Presence of particulate matter: identified as Buprenorphine free base

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
March 13, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 13, 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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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 #: 84132, Exp 02/28/2027, 87693, Exp 03/31/2027
UPC codes
42023-179, 42023-179-05
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 13, 2026

  2. Reported by FDA DRUG

    May 20, 2026

  3. RecallRadar source check

    May 27, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Presence of particulate matter: identified as Buprenorphine free base

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ENDO USA, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: BUPRENORPHINE HYDROCHLORIDE; Brand: BUPRENORPHINE HYDROCHLORIDE. Reason: Presence of particulate matter: identified as Buprenorphine free base. Classification: Class II. Quantity: 34,293 vials. Distribution: USA Nationwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot #: 84132
Exp 02/28/2027
87693
Exp 03/31/2027
UPC Codes
42023-179
42023-179-05
Affected States
ALL
Report Date
May 20, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE