FDA Drug Recalls

Recalls / Active ingredient / Buprenorphine Hydrochloride

Buprenorphine Hydrochloride

10 FDA drug recalls involving the active ingredient “Buprenorphine Hydrochloride.

DateClassProductFirm
2024-05-20Class IIBuprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit withPfizer Inc.
2023-05-03Class IIBuprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-SUN PHARMACEUTICAL INDUSTRIES INC
2022-10-18Class IIBuprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun PharSUN PHARMACEUTICAL INDUSTRIES INC
2021-11-09Class IIBuprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (PAR Sterile Products LLC
2021-03-15Class IIBelbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDCCardinal Health Inc.
2021-03-15Class IIBelbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDCCardinal Health Inc.
2021-02-26Class IIBuprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, DistributeAlvogen, Inc
2020-08-14Class IIBuprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, ManufacHikma Pharmaceuticals USA Inc.
2017-04-28Class IIBuprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single PAR Sterile Products LLC
2014-09-09Class IIBuprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Hospira Inc.