FDA Drugs recall ·
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL… recall
Read the official FDA notice ↗
Product
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
Why was it recalled?
Crystallization; identified as Buprenorphine free base
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0596-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.