Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Buprenorphine HCI Injection Recalled by PAR Sterile Products LLC Due to Crystallization: due to the presence of white, crystalline...
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 HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
Quantity: 122,469 cartons
Why Was This Recalled?
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
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