Warning
ENDO USA Recalls Buprenorphine Hydrochloride
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0527-2026Drug / Pharmaceutical
ENDO USA Recalls Buprenorphine Hydrochloride
ENDO USA, Inc. · Class II — Moderate Risk
Product Description
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Reason for Recall
Crystallization; identified as Buprenorphine free base
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
USA Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. ENDO USA, Inc. initiated the recall on March 13, 2026 affecting 34,293 vials. Crystallization; identified as Buprenorphine free base. The product was distributed in USA Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact ENDO USA, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.