🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: June 12, 2026 Par Health USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Par Health USA, LLC
Reason for Recall:
Crystallization; identified as Buprenorphine free base
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

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

Product Codes/Lot Numbers:

Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0596-2026