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Buprenorphine HCl Injection
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DRUG RECALLMODERATE

Buprenorphine HCl Injection

Par Health is recalling Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.

What to do

Contact your healthcare provider or pharmacy to arrange for the return or replacement of the affected product. Do not use the medication if crystallization is observed.

Recalled
Listed
Updated
Recall No.
D-0596-2026
Agency
FDA
Firm
Par Health USA, LLC
Recall ID
99237
Status
ONGOING

Recall at a glance

Quantity recalled
46,334 units

Why it was recalled

Par Health is recalling Buprenorphine HCl Injection due to the presence of crystallization, which has been identified as Buprenorphine free base. The affected product is a 0.3 mg/mL injection packaged in cartons containing five 1 mL single-dose vials.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Buprenorphine HCl, CIII, Injection

Lot code
82886, 2026
Strength
0.3 mg
NDC / UPC
NDC 42023-179-05

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Product Quality Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-06-18 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification