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Class II · ModerateActive recall

Buprenorphine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Crystallization; identified as Buprenorphine free base

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byPar Health USA, LLC
Brand nameBUPRENORPHINE HYDROCHLORIDE
Generic nameBUPRENORPHINE HYDROCHLORIDE
Active ingredient(s)BUPRENORPHINE HYDROCHLORIDE
Distributed by / forEndo USA, Malvern, PA 19355
NDC42023-179-05
Show the full FDA record
Full product labelBuprenorphine 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
Recalling firmPar Health USA, LLC
DistributionNationwide in the USA.
Quantity46,334 units
Recall initiated2026-06-12
Report date2026-06-24
Recall completed—
Recall numberD-0596-2026
ClassificationClass II
FDA statusOngoing
Origin on fileRochester MI United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.