The FDA enforcement record lists a Class II recall of buprenorphine hydrochloride injection 0.3 mg/mL in 1 mL single-dose vials, manufactured for Endo USA, with Par Health USA as the recalling firm. The stated reason is crystallisation, and the recall was listed as ongoing on 7 October.
Class II means use could cause temporary or medically reversible problems, or that serious harm is remote. This is a parenteral analgesic presentation used in hospital, not the sublingual buprenorphine used to treat opioid use disorder.
It is a US recall. Whether this presentation is supplied in India is not stated in the record.
- The recall covers buprenorphine hydrochloride 0.3 mg/mL injection in single-dose vials.
- The reason given is crystallisation of the product.
- It is a Class II recall: serious harm is judged unlikely.
- Sublingual buprenorphine for opioid use disorder is not named in this notice.
- Inspect vials before use and do not give a solution with visible crystals.
Why it matters
Patients and staff may read 'buprenorphine recall' as affecting opioid-use-disorder treatment when it does not.
Don't overread it
This is a product-quality recall, not a safety finding about buprenorphine itself.
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