Buprenorphine HCl recall
FDA recall D-0596-2026 · initiated Jun 12, 2026
Par Health USA, LLC recalled Buprenorphine HCl in Jun 2026 — an FDA Class II recall (D-0596-2026) because Crystallization; identified as Buprenorphine free base.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Crystallization; identified as Buprenorphine free base
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 46,334 units
Details
- Product
- Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
- Recalling company
- Par Health USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Jun 12, 2026
- FDA report date
- Jun 24, 2026
Frequently asked
- Was Buprenorphine HCl recalled?
- Par Health USA, LLC recalled Buprenorphine HCl in Jun 2026 — an FDA Class II recall (D-0596-2026) because Crystallization; identified as Buprenorphine free base. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Buprenorphine HCl recalled?
- Per the FDA enforcement record, the reason for recall D-0596-2026 was: Crystallization; identified as Buprenorphine free base
- Is a recalled Buprenorphine HCl dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Buprenorphine HCl are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0596-2026.