Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Buprenorphine HCl Recalled by PAR Sterile Products LLC Due to Crystallization: presence of white, crystalline product agglomeration observed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PAR Sterile Products LLC directly.
Affected Products
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Why Was This Recalled?
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About PAR Sterile Products LLC
PAR Sterile Products LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report