Buprenorphine HCl, CIII, Injection, 0.3 mg/mL
Recalled by Par Health USA, LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Par Health USA, LLC has recalled Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 24, 2026 and was initiated on June 12, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, with approximately 46,334 units affected. The company behind the recall is Par Health USA, LLC, based in Rochester, MI. The FDA describes the product as: “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”
Why was Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled?
According to the FDA, the stated reason for the recall is: “Crystallization; identified as Buprenorphine free base.”
What should you do?
If you think you may have bought Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, compare it against the product description and identifying codes (Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Par Health USA, LLC or your local health authority.
About this recall
This recall was distributed in MI. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- June 24, 2026
- Recall started
- June 12, 2026
- Distributed in
- MI
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled?+
According to the FDA: Crystallization;
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Buprenorphine HCl, CIII, Injection, 0.3 mg/mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0596-2026. Information last synced from the FDA on July 5, 2026.