FDAFDA · Food and drugs·Recall number D-0876-2026
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
Published October 7, 2026 · Recall initiated: September 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- Par Health USA, LLC
- Distributor
- U.S. Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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Questions about this recall
Was 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 recalled?
Yes. FDA published recall D-0876-2026 on October 7, 2026. Reported hazard: Crystallization
What should I do if I have this product?
Voluntary: Firm initiated · Letter
How do I know if my unit is part of the recall?
Compare your product details with the notice. Brand: BUPRENORPHINE HYDROCHLORIDE.
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