FDA Drug · D-0596-2026

Buprenorphine 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

Class II · Ongoing

Crystallization; identified as Buprenorphine free base

Affected lots / codes — check yours against thisLot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027

Recalling firm: Par Health USA, LLC, Rochester, MI
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 46,334 units
Distribution: Nationwide in the USA.
Recall initiated: June 12, 2026
Classified: June 17, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0596-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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