Buprenorphine Hydrochloride: 7 recalls on record

Recalled by 1 agency: FDA (7).

First recall on record: October 1, 2014. Most recent: June 24, 2026.

Risk classification: Class II: 7

Most recent recalls

DateAgencyProduct
June 24, 2026FDABuprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx …D-0596-2026
May 20, 2026FDABuprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manu…D-0527-2026
July 3, 2024FDABuprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Steril…D-0564-2024
November 15, 2023FDABuprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1m…D-0087-2024
September 2, 2020FDABuprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use O…D-1533-2020
May 17, 2017FDABuprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), package…D-0698-2017
October 1, 2014FDABuprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile …D-1604-2014

Questions about this brand

How many recalls does Buprenorphine Hydrochloride have?
Recalert has 7 U.S. recalls on record for Buprenorphine Hydrochloride, published between October 1, 2014 and June 24, 2026.
What was the most recent Buprenorphine Hydrochloride recall?
FDA recall D-0596-2026, published June 24, 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
Which agencies have recalled Buprenorphine Hydrochloride products?
Buprenorphine Hydrochloride products appear in recalls from: FDA (7).

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