FDA recall D-0876-2026 · Oct 7, 2026
Par Health USA, LLC: Buprenorphine Hydrochloride recall
Product
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
Reason for recall
Crystallization
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your package, and look for the company's notice on FDA's recalls page. If you have the product and aren't sure, don't use it until you've checked.
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#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027
- Quantity
- 154210 bottles
- Distribution
- U.S. Nationwide
- Recalling firm
- Par Health USA, LLC, Rochester, MI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-08
Source: openFDA enforcement record D-0876-2026 · search recall number D-0876-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 14, 2026, 12:58 AM EDT. The agency notice is the final word.
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