Buprenorphine HCl Injection (PAR Sterile) – Crystallization Risk (2021)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Brand
PAR Sterile Products LLC
Lot Codes / Batch Numbers
Lot No: 343716, Exp. Date: 11/2021, Lot No: 350565, Exp. Date: 07/2022, Lot No: 26921, Exp. Date: 07/2022, Lot No: 36227, Exp. Date: 02/2023
Products Sold
Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
PAR Sterile Products LLC is recalling Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Do due to Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026