Par Health Usa, Llc: Buprenorphine Hydrochloride, Injection 0.3 Mg/ml

Recall Summary Par Health USA is recalling Buprenorphine Hydrochloride Injection 0.3 mg/mL (a prescription pain medication) because the product may contain crystallization, which could affect its quality and effectiveness. The recall affects specific batches distributed nationwide across all U.S. states. This is classified as a Class II recall, meaning the product could cause adverse health effects but is unlikely to result in serious injury.

Recalling firm

Par Health USA, LLC

Product

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

Reason

Crystallization

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-09-08

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/ee9c9aef-7701-4aed-985f-c59a6a6867d7