FDA Drugs recall ·
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only… recall
- Recall number
- D-0876-2026
- Date
- (initiated September 8, 2026)
- Company / brand
- Par Health USA, LLC
870 Parkdale Rd, Rochester, MI, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 154210 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Crystallization
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0876-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.