Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only
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 Hydrochloride, Injection 0.3 mg/mL, Rx Only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on October 7, 2026 and was initiated on September 8, 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 Hydrochloride, Injection 0.3 mg/mL, Rx Only, with approximately 154210 bottles affected. The company behind the recall is Par Health USA, LLC, based in Rochester, MI. The FDA describes the product as: “Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05”
Why was Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only recalled?
According to the FDA, the stated reason for the recall is: “Crystallization.”
What should you do?
If you think you may have bought Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, compare it against the product description and identifying codes (Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Ex…) 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.
Who this recall affects
This recall matters to anyone who bought Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: U.S. Nationwide.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- October 7, 2026
- Recall started
- September 8, 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 Hydrochloride, Injection 0.3 mg/mL, Rx Only 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 Hydrochloride, Injection 0.3 mg/mL, Rx Only?+
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-0876-2026. Information last synced from the FDA on October 13, 2026.