Buprenorphine Hydrochloride Injections Recalled Due to the Presence of Particulate Matter

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for buprenorphine hydrochloride injections, 0.3mg/mL. The affected batches have been identified as Lot 84132 (expires February 2027) and Lot 87693 (expires March 2027), affecting 34 293 vials.
• The recall was initiated by Endo USA, Inc due to the presence of particulate matter, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Buprenorphine hydrochloride injections are used to treat opioid use disorder (OUD) as well as chronic pain.

The FDA has issued a Class II recall for buprenorphine hydrochloride injections, 0.3mg/mL, affecting 34 293 vials. This medication is manufactured and distributed nationwide by Endo USA, Inc. The branch in Rochester, Michigan is the one recalling the drug. The recall was initiated on March 13, 2026, and received a Class II classification on May 11, 2026.

The recall was initiated due to the presence of particulate matter in the product—specifically buprenorphine free base. This deficiency affects Lot 84132 and Lot 87693, which expire in February 2027 and March 2027, respectively. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is low. Endo USA, Inc sent out a public notice via letter; no public press release has been issued for this recall.

Buprenorphine hydrochloride is an opioid medication used to treat OUD by reducing cravings and withdrawal symptoms. It can also be used to relieve moderate to severe pain. Pharmacists should identify and quarantine Lots 84132 and 87693, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. May 20, 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219207