Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Sun Pharmaceutical Industries INC

NDC code

62756-460-83

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0869-2023

Other Buprenorphine recalls

See all

Class II · Moderate risk Ongoing Jun 12, 2026

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous…

Reason Crystallization; identified as Buprenorphine free base

Par Health USA, LLC NDC 42023-179-05 D-0596-2026

Class II · Moderate risk Ongoing Mar 13, 2026

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA…

Reason Crystallization; identified as Buprenorphine free base

ENDO USA, Inc. NDC 42023-179-05 D-0527-2026

Class II · Moderate risk Ongoing May 20, 2024

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For…

Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Pfizer Inc. D-0564-2024

Class III · Low risk Terminated Feb 15, 2023

Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured…

Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the…

AVEVA Drug Delivery Systems, Inc. NDC 60505-7079-05 D-0466-2023

Class III · Low risk Terminated Feb 15, 2023

Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured…

Reason Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the…

AVEVA Drug Delivery Systems, Inc. NDC 60505-7077-05 D-0465-2023