The FDA lists an ongoing Class II recall, dated 7 October 2026, of buprenorphine hydrochloride injection 0.3 mg/mL in packs of five 1 mL single-dose vials. The recall reason given is crystallisation, and the recalling firm is Par Health USA.
A Class II recall covers products that may cause temporary or reversible health effects, where serious harm is considered remote. This product is the parenteral analgesic formulation used for acute pain, not the sublingual or depot forms used to treat opioid use disorder.
The practical step is for pharmacies and wards holding this product to check stock against the recall notice and inspect vials before use. The recall is a US action; whether the affected lots reached other markets is not stated.
- Inspect buprenorphine injection vials for visible crystals or particles before drawing up, and do not use any that are affected.
- The recall covers the 0.3 mg/mL injection only, not sublingual tablets, films or long-acting depot injections.
- Pharmacies holding US-sourced stock should check lot numbers against the FDA notice.
- Patients on buprenorphine for opioid use disorder need no change on account of this recall.
Why it matters
A quality defect in an injectable opioid matters at the bedside, but it does not touch the formulations used for addiction treatment.
Don't overread it
This is a manufacturing quality recall, not a new safety finding about buprenorphine.
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