Par Health USA, LLC recalls Buprenorphine Hydrochloride
- Recalling company
- Par Health USA, LLC
- 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
- Crystallization
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 8, 2026
- Reported
- Oct 7, 2026
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 154210 bottles
- Lot / codes
- 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
- Company location
- Rochester, MI
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0876-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0876-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.