Unrated Drug recall · FDA · Published June 12, 2026

Par Health Buprenorphine Injection Recall: Crystallization Risk

Par Health USA recalls specific buprenorphine injections due to crystallization risk. This may affect patients using these medications. Contact your healthcare provider for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0596-2026Drug Par Health ›

Recall notice

Crystallization; identified as Buprenorphine free base

Take action

Contact the company

Recalling firmPar Health USA, LLC870 Parkdale Rd · Rochester, MI 48307-1740

✎ GovInfoNow plain-language explainer

Par Health USA is recalling certain buprenorphine injections because they may crystallize, potentially causing safety issues. This recall affects patients using these medications under prescription. Read more at govinfonow.com/recall/31198-par-health-buprenorphine-injection-recall-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31198-par-health-buprenorphine-injection-recall-crystallization-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0596-2026

Cite this page

“Par Health Buprenorphine Injection Recall: Crystallization Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31198-par-health-buprenorphine-injection-recall-crystallization-risk. Based on FDA recall #D-0596-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0596-2026%22&limit=1).

Par Health USA, LLC recalled Buprenorphine HCl injection vials due to crystallization hazards, the FDA announced on June 12, 2026. The voluntary Class II recall affects 46,334 units distributed nationwide.

How to tell if you have it

Brand: Par Health
Product: Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton
NDC: 42023-179-05
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027

The hazard

The recall is due to crystallization identified as Buprenorphine free base. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Par Health USA, LLC has 1 other recall on record since 2026-09-08. On 2026-09-08, Par Health recalled Buprenorphine Injections due to crystallization. Other recent recalls of similar products include Endo USA Buprenorphine Injection Recall: Crystallization Risk (2026-03-13), American Regent Epinephrine Injection Recall: Particulate Matter Risk (2026-08-11), and American Health Packaging Buprenorphine Tablets Recall: Label Mix-Up Hazard (2026-08-19).

How to tell if you have this one

Check for the product name: Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton. Look for lot numbers 82886 (expiring 09/30/2026) or 89646 (expiring 05/31/2027).

Brand
Par Health
Category
Drug

Based on the official FDA remedy

What to do — step by step

Contact Healthcare Provider
Reach out to your prescribing doctor or healthcare provider for guidance on next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 12 days after the firm started it.

Jun 12, 2026Firm started the recall
Jun 17, 2026FDA classified it Class II
Jun 24, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31198-par-health-buprenorphine-injection-recall-crystallization-risk">Par Health Buprenorphine Injection Recall: Crystallization Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0596-2026 (June 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0596-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.