Par Health Recalls Buprenorphine Injections Due to Crystallization
Par Health USA recalls 154,210 bottles of Buprenorphine Hydrochloride Injection due to crystallization. Check lot numbers and expiration dates.
Stop using this now
Crystallization
What happened, in plain English
Par Health USA, LLC is recalling Buprenorphine Hydrochloride Injection 0.3 mg/mL because the drug may have crystallized. The recall affects 154,210 bottles distributed nationwide. Crystallization can alter the medication's safety and effectiveness. Read more at govinfonow.com/recall/1443842-par-health-usa-llc-recalls-buprenorphine-hydrochloride-injection-0-3.
Source Summary by GovInfoNow · govinfonow.com/recall/1443842-par-health-usa-llc-recalls-buprenorphine-hydrochloride-injection-0-3 · Updated October 13, 2026 · FDA enforcement record: FDA #D-0876-2026
Cite this page
“Par Health Recalls Buprenorphine Injections Due to Crystallization.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/1443842-par-health-usa-llc-recalls-buprenorphine-hydrochloride-injection-0-3. Based on FDA recall #D-0876-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0876-2026%22&limit=1).
Why it’s dangerous
The presence of crystals in the injection solution can indicate that the drug has degraded or precipitated out of solution. This could lead to inaccurate dosing, blockage of needles, or other adverse health effects if injected.
Who’s affected
Patients prescribed Buprenorphine Hydrochloride Injection who purchased or were administered vials from the specific lots listed in the recall notice.
How to tell if you have this one
Check your vials for the following details: NDC 42023-179-05. Affected lots are 83912 (Exp 10/2026), 84234 (Exp 11/2026), 84990 (Exp 11/2026), 85003 (Exp 12/2026), 86443 (Exp 01/2027), and 89909 (Exp 05/2027). Look for visible crystals in the liquid.
- Brand
Par Health USA- Category
Drug
What to do — step by step
Stop Using the Product
Do not use any vials from the affected lots due to the risk of crystallization.
Contact Healthcare Provider
Speak with your doctor or pharmacist immediately to discuss alternative treatment options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many bottles are being recalled?
A total of 154,210 bottles are included in this recall.
What is the NDC for the recalled product?
The National Drug Code (NDC) for the affected product is 42023-179-05.
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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-0876-2026 (September 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0876-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.