FDAFDA recall D-0596-2026 · Jun 24, 2026
Par Health USA, LLC: Buprenorphine HCl recall
Recall found
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
Reason for recall
Crystallization; identified as Buprenorphine free base
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
- Quantity
- 46,334 units
- Distribution
- Nationwide in the USA.
- Recalling firm
- Par Health USA, LLC, Rochester, MI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-12
Source: openFDA enforcement record D-0596-2026 · search recall number D-0596-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.